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U.S. Department of Health and Human Services

Enforcement Report - Week of September 16, 2015

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box. All devices on the market Class II Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing a device without FDA clearance or approval. Derma Pen, LLC
Food Black Currant Huckleberry, Brioche and Jam Ice Cream Bucket, 313, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Black Currant Huckleberry, Brioche and Jam Pint Case, 215, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Black Currant Huckleberry, Brioche and Jam pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Black Walnut Divinity Ice Cream Bucket, 373, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Black Walnut Divinity Pint Case, 273, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Black Walnut Divinity Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Blue Ice Cream Bucket, 807, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Blue Ice Cream Pint Case, 707, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Blue Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Milk Chocolate Bombay N.3 Ice Cream Bucket, 364, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Bombay, Milk Chocolate Ice Cream Pint Case, 264, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Bombay, Milk Chocolate Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Brambleberry Crisp Ice Cream Bucket, 307, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Brambleberry Crisp Ice Cream Pint Case, 290, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Brambleberry Crisp Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Brown Ice Cream Bucket, 803, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Brown Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. Brown Ice Cream Pint Case, 703, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Brown Butter Almond Brittle Ice Cream Bucket, 308, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Brown Butter Almond Brittle Ice Cream Pint Case, 253, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Brown Butter Almond Brittle Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Buttercup Pumpkin w/Amaretti Cookies Ice Cream Bucket, 304, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Buttercup Pumpkin w/Amaretti Cookies Ice Cream Pint Case, 204, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Buttercup Pumpkin w/Amaretti Cookies Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Cedarwood Vanilla Ice Cream Bucket, 398, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Cedarwood Vanilla Ice Cream Pint Case, 298, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Cedarwood Vanilla Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Cherries Kickapoo Ice Cream Bucket, 356, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Cherries Kickapoo Ice Cream Pint Case, 256, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Cherries Kickapoo Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Cherry Lambic Ice Cream Bucket, 328, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Cherry Lambic Ice Cream Pint Case, 228, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Cherry Lambic Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Chocomole Ice Cream Bucket, 399, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Chocomole Ice Cream Pint Case, 299, Jenis' Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Chocomole Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Cinderella Pumpkin Ice Cream Bucket , 371, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Cinderella Pumpkin Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen. Cinderella Pumpkin Ice Cream Pint Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen. Cinderella Pumpkin Ice Cream Pint Case, 271, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Cloverton Ice Cream Bucket, 351, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Cloverton Ice Cream Pint Case, 251, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Cloverton Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Dark Chocolate Ice Cream Bucket, 311, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Dark Chocolate Ice Cream Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen. Dark Chocolate Ice Cream Indie, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen. Dark Chocolate Ice Cream Half Gallon Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen. Dark Chocolate Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen. Dark Chocolate Ice Cream Pint Case, 201, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Dark Chocolate Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Double-Toasted Coconut Ice Cream Bucket, 349, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Double-Toasted Coconut Ice Cream Pint Case, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Double-Toasted Coconut Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Eclair Ice Cream Bucket, 810, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Eclair Ice Cream Pint Case, 710, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Eclair Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Goat Cheese w/Red Cherries Ice Cream Bucket, 312, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Goat Cheese w/Red Cherries Ice Cream Half Gallon Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen. Goat Cheese w/Red Cherries Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen. Goat Cheese w/Red Cherries Ice Cream Pint Case, 216, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Goat Cheese w/Red Cherries Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Gooey Buttercake Ice Cream Bucket, 820, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Gooey Buttercake Ice Cream Pint Case, 720, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Gooey Buttercake Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Green Ice Cream Bucket, 805, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Green Ice Cream Pint Case, 705, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Green Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Intelligentsia Black Cat Espresso Ice Cream Bucket, 347, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Intelligentsia Black Cat Espresso Ice Cream Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen. Intelligentsia Black Cat Espresso Ice Cream Indie, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen. Intelligentsia Black Cat Espresso Ice Cream Pint Case, 247, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Intelligentsia Black Cat Espresso Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Key Lime Bucket, 337, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Key Lime Pint Case, 237, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Key Lime Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Loveless Biscuits + Peach Jam Ice Cream Bucket, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Loveless Biscuits + Peach Jam Ice Cream Pint Case, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Loveless Biscuits + Peach Jam Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Middle West Whiskey Eggnog Ice Cream Bucket, 372, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Middle West Whiskey Eggnog Ice Cream Half Gallon Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen. Middle West Whiskey Eggnog Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen. Middle West Whiskey Eggnog Ice Cream Pint Case, 272, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Middle West Whiskey Eggnog Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Moonshine Corn Syrup Custard & Pecans Bucket, 361, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Moonshine Corn Syrup Custard & Pecans Pint Case, 261, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Moonshine Corn Syrup Custard & Pecans Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Ndali Estate Vanilla Bean Ice Cream Bucket, 326, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Ndali Estate Vanilla Bean Ice Cream Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen. Ndali Estate Vanilla Bean Ice Cream Indie, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen. Ndali Estate Vanilla Bean Ice Cream Half Gallon Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen. Ndali Estate Vanilla Bean Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen. Ndali Estate Vanilla Bean Ice Cream Pint Case, 240, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Ndali Estate Vanilla Bean Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Orange Bucket, 806, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Orange Pint Case, 706, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Orange Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Oregon Fir Ice Cream Bucket, 363, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Oregon Fir Ice Cream Pint Case, 263, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Oregon Fir Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Dark Chocolate Peppermint Ice Cream Bucket, 331, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Dark Chocolate Peppermint Ice Cream Pint Case, 231, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Dark Chocolate Peppermint Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Pfeffernusse Bucket, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Pistachio & Honey Ice Cream Bucket, 319, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Pistachio & Honey Ice Cream Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen. Pistachio & Honey Ice Cream Indie, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen. Pistachio & Honey Ice Cream Half Gallon Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen. Pistachio & Honey Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen. Pistachio & Honey Ice Cream Pint Case, 209, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Pistachio & Honey Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Pumpernickel Ice Cream Bucket, 376, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Pumpernickel Ice Cream Pint Case, 276, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Pumpernickel Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Queen City Cayenne Ice Cream Bucket, 320, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Queen City Cayenne Ice Cream Pint Case, 211, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Queen City Cayenne Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Raspberry Red Currant, Brioche and Jam Bucket, 316, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Raspberry Red Currant, Brioche and Jam Pint Case, 223, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Raspberry Red Currant, Brioche and Jam Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Red Currant Cloverton Bucket, 377, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Red Currant Cloverton Pint Case, 277, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Red Currant Cloverton Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Riesling Poached Pear Sorbet Bucket, 321, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Riesling Poached Pear Sorbet Half Gallon Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen. Riesling Poached Pear Sorbet Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen. Riesling Poached Pear Sorbet Pint Case, 210, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Riesling Poached Pear Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Roasted Strawberry Buttermilk Ice Cream Bucket, 323, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Roasted Strawberry ButtermilkIce Cream Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen. Roasted Strawberry Buttermilk Ice Cream Indie, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen. Roasted Strawberry Buttermilk Ice Cream Pint Case, 218, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Roasted Strawberry Buttermilk Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Roxbury Road Ice Cream Bucket, 362, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Roxbury Road Ice Cream Pint Case, 262, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Roxbury Road Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Rum Ball Ice Cream Bucket, 384, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Rum Ball Ice Cream Pint Case, 284, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Rum Ball Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Saison Flax Bucket, 357, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Saison Flax Pint Case, 257, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Saison Flax Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Salty Caramel Ice Cream Bucket, 301, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Salty Caramel IIce Cream ndie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen. Salty Caramel Ice Cream Indie, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen. Salty Caramel Ice Cream Half Gallon Case, 400, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen. Salty Caramel Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen. Salty Caramel Ice Cream Pint Case, 200, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Salty Caramel Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Salty Vanilla Custard Bucket, 336, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Salty Vanilla Custard Pint Case, 236, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Salty Vanilla Custard Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Savannah Buttermint Ice Cream Bucket, 388, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Savannah Buttermint Ice Cream Half Gallon Case, 411, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen. Savannah Buttermint Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen. Savannah Buttermint Ice Cream Pint Case, 288, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Savannah Buttermint Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Seven Layer Bar Ice Cream Bucket, 393, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Seven Layer Bar Ice Cream Pint Case, 293, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Seven Layer Bar Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Smoked Chocolate Bucket, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Spiced Purple Yam Bucket, 329, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Spiced Purple Yam Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen. Spiced Purple Yam Indie, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Stauf's Black Coffee Bucket, 355, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Stauf's Black Coffee Pint Case, 203, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Stauf's Black Coffee Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Sun-Popped Corn Bucket, 815, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Sun-Popped Corn Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Sweet Corn & Black Raspberries Ice Cream Bucket, 324, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Sweet Corn & Black Raspberries Ice Cream Pint Case, 219, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Sweet Corn & Black Raspberries Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Sweet Cream Biscuits w/ Jam Ice Cream Bucket, 359, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Sweet Cream Biscuits w/ Jam Ice Cream Pint Case, 259, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Sweet Cream Biscuits w/ Jam Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Sweet Cream w/ Molasses & Peanuts Ice Cream Bucket, 352, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Sweet Cream w/ Molasses & Peanuts Ice Cream Half Gallon Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen. Sweet Cream w/ Molasses & Peanuts Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen. Sweet Cream w/ Molasses & Peanuts Ice Cream Pint Case, 252, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Sweet Cream w/ Molasses & Peanuts Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Sweet Potato w/Torched Marshmallows Ice Cream Bucket, 333, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Sweet Potato w/Torched Marshmallows Ice Cream Pint Case, 233, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Sweet Potato w/Torched Marshmallows Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food The Buckeye State Ice Cream Bucket, 309, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. The Buckeye State Ice Cream Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen. The Buckeye State Ice Cream Indie, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen. The Buckeye State Ice Cream Pint Case, 265, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. The Buckeye State Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food The Milkiest Chocolate in the World Ice Cream Bucket, 325, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. The Milkiest Chocolate in the World Ice Cream Pint Case, 294, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. The Milkiest Chocolate in the World Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Torrone Ice Cream Bucket, 378, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Torrone Ice Cream Pint Case, 278, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Torrone Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Triumph Ice Cream Bucket, 381, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Triumph Ice Cream Pint Case, 281, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Triumph Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Whiskey & Pecans Ice Cream Bucket, 335, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Whiskey & Pecans Ice Cream Pint Case, 234, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Whiskey & Pecans Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food White Chocolate Coconut Bucket, 819, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. White Chocolate Coconut Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food White Chocolate Peppermint Ice Cream Bucket, 375, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. White Chocolate Peppermint Pint Case, 275, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. White Chocolate Peppermint Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Wildberry Lavender Ice Cream Bucket, 327, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Wildberry Lavender Ice Cream Pint Case, 220, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Wildberry Lavender Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Wintermint Bucket, 310, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Yazoo Sue w/Rosemary Bar Nuts Ice Cream Bucket, 392, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Yazoo Sue w/Rosemary Bar Nuts Ice Cream Pint Case, 292, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Yazoo Sue w/Rosemary Bar Nuts Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Yellow Bucket, 813, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Yellow Pint Case, 713, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Yellow Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Apricot, Brioche and Jam Bucket, 300, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Apricot, Brioche and Jam Pint Case, 207, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Apricot, Brioche and Jam Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Askinosie Dark Milk Chocolate Ice Cream Bucket, 353, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Askinosie Dark Milk Chocolate Ice Cream Pint Case, 213, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Askinosie Dark Milk Chocolate Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Backyard Mint Ice Cream Bucket, 302, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Backyard Mint Ice Cream Pint Case, 214, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Backyard Mint Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Banana French Toast Bucket, 354, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Banana French Toast Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen. Banana French Toast Pint Case, 254, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Banana French Toast Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Banana Pudding Bucket, 811, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Banana Pudding Pint Case, 711, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Banana Pudding Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Bananas & Honey Ice Cream Bucket, 374, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Bangkok Peanut Ice Cream Bucket, 303, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Bangkok Peanut Ice Cream Pint Case, 212, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Bangkok Peanut Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Batdorf Black Coffee Bucket, 366, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Batdorf Black Coffee Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen. Batdorf Black Coffee Indie, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen. Batdorf Black Coffee Pint Case, 266, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Batdorf Black Coffee Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Batdorf Coffee w/ Cream & Sugar Bucket, 383, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Batdorf Coffee w/ Cream & Sugar Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Birch + Marshmallows Ice Cream Bucket, 379, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Birch + Marshmallows Pint Case, 279, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Birch + Marshmallows Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Black Bucket, 812, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Black Pint Case, 712, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Black Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Bergamot Frozen Yogurt Bucket, 348, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Bergamot Frozen Yogurt Pint Case, 248, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Bergamot Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Black Currant Frozen Yogurt Bucket, 305, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Black Currant Frozen Yogurt Pint Case, 217, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Black Currant Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Buttermilk, Grapefruit Frozen Yogurt Bucket, 338, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Buttermilk, Grapefruit Frozen Yogurt Pint Case, 225, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Buttermilk, Grapefruit Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Buttermilk, Lemon & Blueberry Frozen Yogurt Bucket, 814, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Buttermilk, Lemon & Blueberry Frozen Yogurt Pint Case, 714, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Buttermilk, Lemon & Blueberry Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Lemon ButtermilkFrozen Yogurt Bucket, 809, Jenis Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Buttermilk, Lemon Frozen Yogurt Indie Case, 103, Jenis Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen. Buttermilk, Lemon Frozen Yogurt Indie, Jenis Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen. Buttermilk, Lemon Frozen Yogurt Pint Case, 709, Jenis Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Buttermilk, Lemon Frozen Yogurt Pint, Jenis Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Buttermilk, Lime Cardamom Frozen Yogurt Bucket, 306, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Buttermilk, Lime Cardamom Frozen Yogurt Pint Case, 206, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Buttermilk, Lime Cardamom Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Buttermilk, Mango Lassi Frozen Yogurt Bucket, 341, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Buttermilk, Mango Lassi Frozen Yogurt Pint Case, 235, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Buttermilk, Mango Lassi Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Buttermilk, Passion Fruit Frozen Yogurt Bucket, 340, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Buttermilk, Red Raspberry Frozen Yogurt Bucket, 339, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Buttermilk, Red Raspberry Frozen Yogurt Pint Case, 226, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Buttermilk, Red Raspberry Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Cranberry Parfait Buttermilk Frozen Yogurt Bucket, 382, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Cranberry Parfait Buttermilk Frozen Yogurt Pint Case, 282, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Cranberry Parfait Buttermilk Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Green Tomato Buttermilk Frozen Yogurt Buckets, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Guava Buttermilk Frozen Yogurt Bucket, 342, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Huckleberry Frozen Yogurt Bucket, 343, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Huckleberry Frozen Yogurt Pint Case, 243, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Huckleberry Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Lemon & Blueberries Frozen Yogurt Bucket, 314, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Lemon & Blueberries Frozen Yogurt Half Gallon Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen. Lemon & Blueberries Frozen Yogurt Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen. Lemon & Blueberries Frozen Yogurt Pint Case, 267, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Lemon & Blueberries Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Lemon Frozen Yogurt Bucket, 315, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Lemon Frozen Yogurt Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen. Lemon Frozen Yogurt Indie, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen. Lemon Frozen Yogurt Pint Case, 208, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Lemon Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Mango Lassi Frozen Yogurt Bucket, 391, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Mango Lassi Frozen Yogurt Pint Case, 297, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Mango Lassi Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Pineapple Cake Frozen Yogurt Bucket, 358, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Pineapple Cake Frozen Yogurt Pint Case, 258, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Pineapple Cake Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Rainbow Frozen Yogurt Bucket, 344, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Rainbow Frozen Yogurt Pint Case, 244, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Rainbow Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Red Raspberry Frozen Yogurt Bucket, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Red Raspberry Frozen Yogurt Poppin' J Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 25 containers per case, frozen. Red Raspberry Frozen Yogurt Pint Case, 241, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Red Raspberry Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Tart, Lemon Buttermilk Frozen Yogurt Bucket, 380, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Tart, Lemon Buttermilk Frozen Yogurt Pint Case, 280, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Tart, Lemon Buttermilk Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Watermelon Buttermilk Frozen Yogurt Bucket, 817, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Watermelon Buttermilk Frozen Yogurt Pint Case, 717, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Watermelon Buttermilk Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Black Currant Lambic Sorbet Bucket, 385, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Black Currant Lambic Sorbet Pint Case, 285, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Black Currant Lambic Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Blood Orange Sorbet Bucket, 387, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Blood Orange Sorbet Pint Case, 287, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Blood Orange Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Cantaloupe & Sun Tea Sorbet Bucket, 360, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Cantaloupe & Sun Tea Sorbet Pint Case, 260, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Cantaloupe & Sun Tea Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Wheatgrass, Pear, & Vinho Verde Sorbet Bucket, 808, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Wheatgrass, Pear, & Vinho Verde Sorbet Pint Case, 708, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Bitter Lemon Ice Bucket, 816, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Bitter Lemon Ice Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Blue Raspberry Ice Bucket, 818, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Blue Raspberry Ice Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Guava Buttermilk Frozen Yogurt Sandwich Case, 507, Jeni's Splendid Ice Creams, LLC, 5oz sandwich, paper box, 14 boxes per case, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Orchid Vanilla Macaroon Ice Cream Sandwich Case, 503, Jeni's Splendid Ice Creams, LLC, 5oz sandwich, paper box, 14 boxes per case, frozen. Mini Orchid Vanilla Macaroon Ice Cream Sandwich Case, Jeni's Splendid Ice Creams, LLC, mini Sandwich, paper box, 8 sleeves per case, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Orchid Vanilla Macaroon Sandwich, Jeni's Splendid Ice Creams, LLC, 5oz sandwich, paper box, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Dark Chocolate Hazelnut Macaroon Sandwich Case, 502, Jeni's Splendid Ice Creams, LLC, 6.2oz sandwich, paper box, 14 boxes per case, frozen. Dark Chocolate Hazelnut Macaroon Sandwich, Jeni's Splendid Ice Creams, LLC, 6.2oz sandwich, paper box, individually packed, frozen. Mini Dark Chocolate Hazelnut Macaroon Case, Jeni's Splendid Ice Creams, LLC, mini Sandwich, paper box, 8 sleeves per case, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Pfeffernusse Macaroon Sandwich Case - for scoop shop orders, Jeni's Splendid Ice Creams, LLC, 6oz sandwich, paper box, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Pfeffernusse Sandwich - NOT FOR SCOOP SHOP ORDERS, Jeni's Splendid Ice Creams, LLC, 6oz sandwich, paper box, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Salty Caramel Macaroon Case, 504, Jeni's Splendid Ice Creams, LLC, 6oz sandwich, paper box, 14 boxes per case, frozen. Salty Caramel Macaroon Sandwich, Jenis Splendid Ice Creams, LLC, 6oz sandwich, paper box, individually packed, frozen. Mini Salty Caramel Macaroon Case, Jenis Splendid Ice Creams, LLC, mini Sandwich, paper box, 8 sleeves per case, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Smoked Dark Chocolate Macaroon Ice Cream Sandwich Case, Jeni's Splendid Ice Creams, LLC, 6-oz sandwich, paper box, 14 boxes per case, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Snowy Coconut Macaroon Ice Cream Sandwich Case, 515, Jeni's Splendid Ice Creams, LLC, 6oz sandwich, paper box, 14 boxes per case, frozen. Snowy Coconut Macaroon Ice Cream Sandwich, Jeni's Splendid Ice Creams, LLC, 6oz sandwich, paper box, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Rum Ball Split Case, Jenis Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen. Rum Ball Split, Jenis Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Wintermint Sandwich Case, 506, Jeni's Splendid Ice Creams, LLC, 6oz sandwich, paper box, 14 boxes per case, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Ohio Maple Brittle Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Sweet Cream Ice Cream Half Gallon Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen. Sweet Cream Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen. Sweet Cream Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Mini Chocolate Truffle Sandwich Sleeve, Jeni's Splendid Ice Creams, LLC, mini Sandwich, paper box, 7 sandwiches per sleeve, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Mini Dark Chocolate Hazelnut Sandwich, Jeni's Splendid Ice Creams, LLC, mini Sandwich, paper box, individually packed, frozen. Mini Dark Chocolate Hazelnut Sleeve, Jeni's Splendid Ice Creams, LLC, mini Sandwich, paper box, 7 sandwiches per sleeve, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Mini Lemon-Orchid Sandwich Case, Jeni's Splendid Ice Creams, LLC, mini Sandwich, paper box, 8 sleeves per case, frozen. Mini Lemon-Orchid Sandwich Sleeve, Jeni's Splendid Ice Creams, LLC, mini Sandwich, plastic bag, 7 sandwiches per sleeve, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Mini Orchid Vanilla Macaroon Case, Jenis Splendid Ice Creams, LLC, mini Sandwich, paper box, 8 sleeves per case, frozen, 7 sandwiches per sleeve, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Mini Salty Caramel Sandwich, Jeni's Splendid Ice Creams, LLC, mini Sandwich, paper box, individually packed, frozen. Mini Salty Caramel Sleeve, Jeni's Splendid Ice Creams, LLC, mini Sandwich, paper box, 7 sandwiches per sleeve, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Askinosie Dark Milk Chocolate Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Beet + Grapefruit Shrub Sorbet Pint Case, 205, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Beet + Grapefruit Shrub Ssorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Eggnog Special Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Feuerzangenbowle Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Hot Toddy Sorbet Pint Case, 202, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Hot Toddy Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Smoked Cassia Cinnamon Ice Cream Pint Case, 224, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Smoked Cassia Cinnamon Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food White House Blueberry Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Apricot Frozen Yogurt Pint Case, 238, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Apricot Frozen Yogurt Pint, Jenis Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Grapefruit Frozen Yogurt Pint Case, 296, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Grapefruit Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Passion Fruit Sorbet Pint Case, 289, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Passion Fruit Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. Passion Fruit Sorbet Pint Case, 289, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Raspberry Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. Raspberry Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Red Raspberry Sorbet Pint Case, 286, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Red Raspberry Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Sugar Plum Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food White Grapefruit Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Food Blackout Terrine Slice, Jeni's Splendid Ice Creams, LLC, Slice, plastic bag, individually packed, frozen. Blackout Terrine Slice Case, Jeni's Splendid Ice Creams, LLC, Slice, plastic bag, 12 slices per case, frozen. All lots distributed were between July 1, 2013 and April 22, 2015. Class I Product may be contaminated with Listeria monocytogenes. Jeni's Splendid Ice Creams LLC
Biologics Red Blood Cells Leukocytes Reduced, Irradiated W128715061081 Class III Irradiated Red Blood Cells, not manufactured according to specifications, were distributed. Delta Blood Bank
Devices OmniPod® Insulin Management System. Only the OmniPod® device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. Lot Numbers: L40806, L40811, L40895, L40976, L41014, L41025, L41067, L41162, L41171, L41197, L41198, L41250 Class I OmniPods® (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin Insulet Corporation
Devices OmniPod® Insulin Management System. Only the OmniPod® device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. Lot Numbers: L40771, L40892, L40901, L40905, L40997, L41199, L41208 Class I OmniPods® (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin Insulet Corporation
Food CocoNoNut CACAO-NECTAR BAR, Honey Mama's brand, Net wt. 2.5 oz. (70.8 g), UPC 8 54835 00406 7 Square in size, 3"X3" with a bright orange label around a butcher paper wrapper. 12 bars/case Expiration Date 121815 Class I CocoNoNut CACAO-NECTAR BAR because it may contain undeclared almond. Nectar Foods LLC
Devices Dimension® CREA (Creatinine) and Dimension Vista® CREA (Creatinine); The CREA method used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatinine in human serum, plasma and urine. Dimension CREA Lot Numbers: DB5195 FA5211 EA5233 DA5258 FA5275 BA5293 EA5315 EA5316 GA5342 FA5351 FA5352 FA6006 BA6026 BA6027 EB6047 GB6076 GA6097 BA6111 BA6112 FB6139 with expiration dates: 2015-07-14 2015-07-30 2015-08-21 2015-09-15 2015-10-02 2015-10-20 2015-11-11 2015-11-12 2015-12-08 2015-12-17 2015-12-18 2016-01-06 2016-01-26 2016-01-27 2016-02-16 2016-03-16 2016-04-06 2016-04-20 2016-04-21 2016-05-20 Dimension Vista CREA Lot Numbers: 14177BB 14212BD 14234BH 14261BC 14280BA 14301BB 14321AC 14346AC 15012AA 15042BA 15054AB 15076BA 15091BA 15125BB 15125BA 15141AA with expiration dates: 2015-06-26 2015-07-31 2015-08-22 2015-09-18 2015-10-07 2015-10-28 2015-11-17 2015-12-12 2016-01-12 2016-02-11 2016-02-23 2016-03-16 2016-03-31 2016-05-04 2016-05-04 2016-05-22 Class II Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results up to - 12.7% and -22% respectively, for a creatinine concentration of 1.5 mg/dL when hemolysis exceeds 200 mg/dL and 300 mg/dL respectively. Siemens Healthcare Diagnostics, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W115115114843Y-part 1; W115115114843Y-part 2 Class II Blood products, which did not meet the criteria for leukoreduced products, were distributed. Lifesouth Community Blood Centers - Montgomery Region
Biologics Red Blood Cells Leukocytes Reduced W038515701639; W038515700716 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Walter L. Shepeard Community Blood Center, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W2906150654602; W2906150654601 Class II Blood products, which did not meet acceptable product specifications, were distributed. Penrose-St Francis Health Services Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W043214074105; W043214009649 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Assurance Inc
Biologics Blood and Blood Products for Reprocessing W043214074105; W043214009649 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Assurance Inc
Biologics Source Plasma 3100141865; Class II Blood product, collected from a donor who had been incarcerated, was distributed. Talecris Plasma Resources, Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W201615221855; W201615221855; Class II Blood products, in which quality control and distribution/failure to quarantine unit due to medical history, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced W036315388252; Class II Blood product, which quality control and distribution of product did not meet specifications, was distributed. BloodCenter of Wisconsin, Inc
Drugs Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-368-01 lot #s: 6669101 & 6669201, exp 12/15 and 6708201 & 6708301, exp 8/16 Class III Chemical Contamination; benzophenone leached from the product label varnish Mutual Pharmaceutical Company, Inc.
Drugs Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01 lot #s: 6662801 & 6662901, exp 10/15, 6689601, exp 4/16, 6689701, exp 5/16 and 6708401, 8/16 Class III Chemical Contamination; benzophenone leached from the product label varnish Mutual Pharmaceutical Company, Inc.
Drugs Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co Inc., Philadelphia, PA --- NDC 53489-370-01 lot #s: 6667301 & 6667401, exp 11/15 and 6699201, exp 6/16 Class III Chemical Contamination; benzophenone leached from the product label varnish Mutual Pharmaceutical Company, Inc.
Drugs Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 54738-912-01 lot #s 6671801, exp 12/16 and 6706401, exp 7/17 Class III Chemical Contamination; benzophenone leached from the product label varnish Mutual Pharmaceutical Company, Inc.
Drugs Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-913-01 lot #s: 6655001, exp 8/16, 6679801, exp 2/17, 6690302, exp 4/17 and 6706001, exp 7/17 Class III Chemical Contamination; benzophenone leached from the product label varnish Mutual Pharmaceutical Company, Inc.
Drugs Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-914-01 lots# 6671901, exp 12/16, 6679901, exp 2/17, 6694201, exp 5/17, 6697901, exp 6/17 and 6704201, exp 7/17 Class III Chemical Contamination; benzophenone leached from the product label varnish Mutual Pharmaceutical Company, Inc.
Drugs DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w) Patient Preoperative Skin Preparation, supplied in a) 0.9 fl oz, 26 mL Single Use Applicator w/urethane sponge and 2-count Cotton-tipped swabs per pouch, packaged in 20 pouches per case (NDC 17518-0011-08, UPC (01) 0 03 17518 01108 5) and b) 0.2 fl oz, 6 mL Single Use Applicator w/urethane sponge per pouch, packaged in 50 pouches per case (NDC 17518-0011-07, UPC (01) 0 03 17518 01107 8), OTC, Made in U.S.A. by 3M Health Care, 2510 Conway Ave., St. Paul, MN 55144. Lot#: a) 2016-09EE, 2016-09EF, 2016-09EG, Exp 9/30/16; b) 2016-08DC, Exp 8/31/16. Class II Chemical contamination: Product may be contaminated with a toxic compound. 3M Company - Health Care Business
Devices ADVIA Centaur® Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay. Lot Number/Expiration: 54942 2015-11-17; 56230 2015-11-17; 70673 2015-11-17 Class II Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay. Siemens Healthcare Diagnostics, Inc
Biologics Fresh Frozen Plasma W120614208450, W120614206867 Class II Blood products, collected from a donor who was taking the medication Proscar, were distributed. Michigan Blood
Biologics Platelets Pooled Leukocytes Reduced W120614183888, W120614381592 Class II Blood products, collected from a donor who was taking the medication Proscar, were distributed. Michigan Blood
Biologics Red Blood Cells Leukocytes Reduced W120614208450, W120614206867, W120614205558, W120614204181 Class II Blood products, collected from a donor who was taking the medication Proscar, were distributed. Michigan Blood
Biologics Platelets Pheresis Leukocytes Reduced W036815281290, W036815281291, W036815281292, W036815306017 Class III Blood products, which may have been exposed to unacceptable temperatures during shipment, were distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W115915251347, W115915251334 Class III Blood products, collected using a mixer/scale device which failed quality control testing, were distributed. Central California Blood Center
Devices Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic spine using bone screws, locking plugs, and various types of rods, hooks, and lateral connectors. One of the instruments used with this system is the Lineum Occipital Screw Starter with the inner shaft subassembly. The system comes with a fixed shaft Lineum Occipital Screw Driver, and a 90° driver in order to retain and drive the screw into the occipital bone. P/N 14-525050 Lot Number 001219 P/N 14-525057 Lot Number 001220 Class II Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design control activities. Biomet Spine, LLC
Devices Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration; Manufactured by: Elcam Medical ACAL, Israel. Sterile, Quantity 20. Elcam Part Number: 572808; lot numbers: 1270243601, 1070181601, 1170205601, 1070178501, 1070181601, 1070178501 Elcam Part Number: 572452; lot  ...
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Class II Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination. Elcam Medical, Inc.
Devices Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., USA. Sterile Elcam Part Number: 470306; lot numbers: 1370256602, 1370263901, 370263902, 1370271301, 1370274101, 1470288601, 1470288602, 1470298801, 1470306701, 1470312401 Elcam Part Number: 470307; lot numbers: 1370254802, 1370266801, 370271401, 1370282101, 1470288701, 1470293001, 1470295901 Elcam Part Number: 471601; lot numbers: 1270239001, 1370266601, 1370271501, 1370278801 Elcam Part Number: 471604; lot numbers: 147029310, 1470306801, 1470310201, 1470312501 Elcam Part Number: 477101; lot numbers:  ...
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Class II Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination. Elcam Medical, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated Washed W041015109489Y; Class III Blood product, in which component not prepared in accordance with specifications, was distributed. United Blood Services
Biologics Red Blood Cells Leukocytes Reduced W036814563012; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. OneBlood, Inc.
Drugs Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48 Lot #: 151900249M, Exp 09/09/15 Class II Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette. Pharmedium Services, LLC
Biologics Red Blood Cells Leukocytes Reduced W043215021240; Class II Blood product, in which donor gave history which warranted deferral or follow up and was not deferred or follow up questions was not asked, was distributed. Blood Assurance Inc
Biologics Red Blood Cells Leukocytes Reduced W043214098501; Class II Blood product, in which donor gave history which warranted deferral or follow up and was not deferred or follow up questions was not asked, was distributed. Blood Assurance Inc
Biologics Plasma Frozen within 24 hours (FP24) W071215013642; Class II Blood product, in which quality control and distribution of product did not meet specifications, was distributed. Medic Inc
Biologics Platelets Pheresis Leukocytes Reduced W044615328317; Class II Blood product, for which the quality control testing was incomplete, was distributed. Gulf Coast Regional Blood Center
Drugs METHOCARBAMOL TABLETS, USP 500 mg, 500 Count Bottles, Rx Only. Manufactured by AustarPharma LLC, Edison, NJ 08837, USA, Packaged by GSMS Incorporated, Camarillo, CA 93012, USA, NDC: 60429-118-05. Lot # GS007849, Expiry: 02/2017 Class III Presence of Foreign Substance: Presence of hair. Golden State Medical Supply Inc.
Devices Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, and heart rate. Lot #14A18, PN: 6800F-PA00001, Serial Numbers: DU- 46002583, DU-46002587, DU-46002588, DU-46002589, DU-46002592, DU-46002594, DU-46002595, DU-46002596, DU-46002599, DU-46002600, DU-46002601, DU-46002605 and DU-46002606 Class II Mindray has identified an issue where the DPM 7 Monitor may display a black screen. Mindray DS USA, Inc. dba Mindray North America
Devices 2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plating System for trauma and reconstructive procedures of small bones. TSL002605 Class II Gridlock screw driver bits for the Gridlock Plating System were identified to be out of specification and have the potential for shallow engagement between the driver and the screw, resulting in an increased likelihood of stripping screw heads intraoperatively. Specifically, the minor diameter of the drive feature is above the specification, potentially reducing the engagement between the driver and the screw head. Trilliant Surgical Ltd.
Devices CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. 500A, 500AHCT, 500AV, 500AVHCT CDI Blood Parameter Monitoring System 500; software version 1.69. Class II Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69. Terumo Cardiovascular Systems Corporation
Devices Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440. Model Number 14-521614B, lot number 375440. Class II Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440. Biomet Spine, LLC
Food IQF Red Tart Cherries, 30 lbs., 2/5 lb packages/case, 4/5 lb. packages per case; packed in cartons, square plastic pails, and poly bag in cartons; Nature Blessed Red Tart Cherries, 4/40 oz. packages per case. Lot Codes: 15190 15191 15196 15198 15200 15201 15202 15203 15204 15205 15212 15215 43145 43146 43147 43148 43149 43150 43151 43152 43153 43155 43156 43157 43158 43159 43160 43161 43162 43163 43164 43165 43166 43167 43168 43169 43170 43171 43172 43173 43174 43175 43176 43177 43178 43179 43180 43181 43182 43183 43184 43583 43584 43585 43586 43587 43588 43589 43590 43591 43592 43593 43594 43595 43596 43597 43598 43599 43600 43601 43602 43603 Class II Potential for adulteration - elevated mold, yeast, and coliform counts Coloma Frozen Foods, Inc.
Food Red Tart Pitted Cherries, 5 Parts Fruit and 1 Part Sugar, 30 lbs. bulk pails, 15 lbs, in bulk pails Lot Codes: 15190 15191 15196 15198 15200 15201 15202 15203 15204 15205 15212 15215 43145 43146 43147 43148 43149 43150 43151 43152 43153 43155 43156 43157 43158 43159 43160 43161 43162 43163 43164 43165 43166 43167 43168 43169 43170 43171 43172 43173 43174 43175 43176 43177 43178 43179 43180 43181 43182 43183 43184 43583 43584 43585 43586 43587 43588 43589 43590 43591 43592 43593 43594 43595 43596 43597 43598 43599 43600 43601 43602 43603 Class II Potential for adulteration - elevated mold, yeast, and coliform counts Coloma Frozen Foods, Inc.
Food Red Tart Pitted Cherries, Straight Packed (No Sugar), 5 lbs. bulk pails, 30 lbs, in bulk pails Lot Codes: 15190 15191 15196 15198 15200 15201 15202 15203 15204 15205 15212 15215 43145 43146 43147 43148 43149 43150 43151 43152 43153 43155 43156 43157 43158 43159 43160 43161 43162 43163 43164 43165 43166 43167 43168 43169 43170 43171 43172 43173 43174 43175 43176 43177 43178 43179 43180 43181 43182 43183 43184 43583 43584 43585 43586 43587 43588 43589 43590 43591 43592 43593 43594 43595 43596 43597 43598 43599 43600 43601 43602 43603 Class II Potential for adulteration - elevated mold, yeast, and coliform counts Coloma Frozen Foods, Inc.
Cosmetics My Fair Baby brand Baby Wipes, Blue package, Item No. 10485-24, 80 Baby Wipes, 24 packages per case Product Code 160.15004 Class II The imported baby wipes were found to be contaminated with bacteria based on FDA sampling and analysis. Delta Brands Inc.
Cosmetics My Fair Baby brand Baby Wipes, Pink package, Item No. 10486-24, 80 Baby Wipes per package, 24 packages per case Product Code 160.15004 Class II The imported baby wipes were found to be contaminated with bacteria based on FDA sampling and analysis. Delta Brands Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated W038215016824; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Kentucky Blood Center Inc
Devices Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis all codes Class II The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks. Smith & Nephew, Inc.
Devices Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74120150 (50 MM), 74122150 (50 MM), 74122152 (52 MM), 74120152 (52 MM), 74120154 (54 MM) Product Usage: Hip joint prosthesis all codes Class II The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks. Smith & Nephew, Inc.
Devices Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), 74120254 (54 MM) Product Usage: Hip joint prosthesis all codes Class II The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks. Smith & Nephew, Inc.
Devices MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status. 759625A 759884A 759491A 762355A Class II Medivators has recalled a subset of their Hemocor High Performance Hemoconcentrators, due to low ultrafiltration performance that is below product specification. Medivators includes a single lot (759491A) of model HPH-700 in this recall. Based on additional information provided by the manufacturer, Medtronic has made the precautionary decision to also include specific lots of models HPH-400TS and HPH-1000TS and a 2nd lot of model HPH-700. These potentially affected units have been distributed as stand-alone devices and in specific lots of Medtronic Perfusion Tubing packs. Medtronic Perfusion Systems
Devices MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, HY8R66R3, HY2U43R9, 8C72R4, BB5J59R19, 6B65R3, TL7M46R7, TL2Q68R17, 7U65R2, M074704B, M230002A, BB7M38Rll, M450013B, BB8N86R4, HY2U43R9, 8C72R4, M650123A, HY8R55R ,TL7M46R7, M971406C, M450013B, 7U65R2, M394415A, M450013B. Enables the perfusionist to manage the patient's hematocrit and fluid status. 209050007 209087876 209107465 209135076 209162502 209195930 209241496 209241613 209270018 209270092 209297994 209298091 209298094 209310403 209326025 209373545 209388464 209396017 209401269 209401312 209415313 209431890 209464644 209512240 209556873 209621268 209644548 209653827 Class II Medivators has recalled a subset of their Hemocor High Performance Hemoconcentrators, due to low ultrafiltration performance that is below product specification. Medivators includes a single lot (759491A) of model HPH-700 in this recall. Based on additional information provided by the manufacturer, Medtronic has made the precautionary decision to also include specific lots of models HPH-400TS and HPH-1000TS and a 2nd lot of model HPH-700. These potentially affected units have been distributed as stand-alone devices and in specific lots of Medtronic Perfusion Tubing packs. Medtronic Perfusion Systems
Devices Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428050-12, 428050-13 and 428050-14; The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port. Model numbers: 428050-12. 428050-13 and 428050-14; all lots Class II Intuitive Surgical has found that in certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. Intuitive Surgical, Inc.
Devices Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428053-12, 428053-15. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port. Model numbers: 428053-12, 428053-15. ; all lots Class II Intuitive Surgical has found that in certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. Intuitive Surgical, Inc.
Devices Cadiere Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428055-12, 428055-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port. Model numbers: 428055-12, 428055-13.. ; all lots Class II Intuitive Surgical has found that in certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. Intuitive Surgical, Inc.
Devices Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428056-12, 428056-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port. Model numbers: 428056-12, 428056-13; all lots Class II Intuitive Surgical has found that in certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. Intuitive Surgical, Inc.
Devices Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428058-12, 428058-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port. Model numbers: 428058-12, 428058-13; all lots Class II Intuitive Surgical has found that in certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. Intuitive Surgical, Inc.
Devices Crocodile Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428059-12, 428059-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port. Model numbers: 428059-12, 428059-13; all lots Class II Intuitive Surgical has found that in certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. Intuitive Surgical, Inc.
Devices Maryland Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428080-04, 428080-05. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port. Model numbers: 428080-04, 428080-05; all lots Class II Intuitive Surgical has found that in certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. Intuitive Surgical, Inc.
Devices Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428088-12, 428088-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port. Model numbers: 428088-12, 428088-13; all lots Class II Intuitive Surgical has found that in certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. Intuitive Surgical, Inc.
Devices Fenestrated Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428093-12, 428093-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port. Model numbers: 428093-12, 428093-13; all lots Class II Intuitive Surgical has found that in certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. Intuitive Surgical, Inc.
Drugs Surgicept (Ethyl alcohol 70% w/w) WATERLESS Surgical Hand Scrub & Healthcare Personnel Handwash in 1150 mL bottles. MARKETED BY: CafeFusion, Leawood, KS 66211, MANUFACTURED FOR: HEALTHPOINT, LTD Ft. Worth, Texas 76107, MANUFACTURED BY: DPT LABORATORIES, LTD 3300 Research Plaza Brooks City-Base, Texas 78235. NDC: 0064-1080-11 Lot #: GBDM, Exp 1/2016 Class II Chemical contamination; Naphthalene compound identified in the product after complaints of a petroleum odor Healthpoint, Ltd
Drugs CVS SUGAR FREE BLACK CHERRY COUGH DROPS (MENTHOL-COUGH SUPPRESSANT), Packaged in a) 25 Drop Bags (UPC: 050428 448526) and b) 36 drop bags (UPC: 050428 476581), Over the Counter. Distributed by: CVS Pharmacy, Inc., One CVS Drive Woonsocket, RI 02895. a) Lot #: 50122U3, Expiry: 01/2017; Lot #: 50122U1, Expiry: 01/2017; and b) Lot #: 50122U2, Expiry: 01/2017. Class III Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops. Bestco, Inc.
Biologics LABType LABType HD Class II DRB1 Typing Test Catalog ID: RSSOH2B1 Lot Number: 009 One Lambda- A Thermo Fisher Scientific Brand 21001 Kittridge Street, Canoga Park, CA 91303 USA Catalog ID: RSSOH2B1 Lot Number: 009 Batches: 1-36 Article Number: RSSO-LTYP-PI, Rev 24 Class III Misbranded HLA Typing Assay was distributed. One Lambda Inc
Biologics Cornea CW111739OD; CW111739OS; Class III Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Eye Bank Of Wisconsin, Inc.
Drugs ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per carton, Manufactured for OCULUS SURGICAL, Port St. Lucie, FL 34986, NDC 62144-5510-05 Lot # V0415F, Exp 10/16 Class III Falied pH specification Oasis Medical, Inc.
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