• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of February 11, 2015

  • Print
  • Share
  • E-mail
-
Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Food Arriba! 16 oz. Chili Con Queso-Hot; 6 units per case Lot: 27DEC16 Class II Product may contain undeclared wheat. Riba Foods Inc
Food Salpica 11.5 oz., 16 oz., Salsa Con Queso; 12 units per case Lot: 14NOV15, 16NOV15, 10SEP15, 18SEP15, 24SEP15, 09OCT15, 15OCT15, 04NOV15, 08NOV15, 14NOV15, 02DEC15, 07DEC15, 14DEC15, 18DEC15, 27DEC15, 10JAN16, 18JAN16, 28JAN16, 03FEB16, 11FEB16, 20FEB16, 21FEB16 Class II Product may contain undeclared wheat. Riba Foods Inc
Food Salpica 8 oz. Ballpark Nacho; 6 units per case Lot: 12SEP14, 19SEP14, 08OCT14, 29OCT14, 21NOV14, 27NOV14, 22JAN15, 08FEB15 Class II Product may contain undeclared wheat. Riba Foods Inc
Food Salpica 8 oz. Black Bean Nacho; 6 units per case Lot: 08OCT14, 21DEC14 Class II Product may contain undeclared wheat. Riba Foods Inc
Food Crate & Barrel 11.5 oz. Monterey Jack Queso Dip; 12 units per case Lot: 10JAN16 Class II Product may contain undeclared wheat. Riba Foods Inc
Food Salpica 16 oz. Jalapeno Jack Queso Dip; 6 units per case Lot: 09OCT15, 14OCT15, 25OCT15, 30OCT15, 08NOV15, 02DEC15, 14DEC15, 21DEC15, 27DEC15, 28JAN16 Class II Product may contain undeclared wheat. Riba Foods Inc
Devices Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Assembly Part Number 820-95443-008. A cassette based multi-function infusion system. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual. The pole clamp assembly is used to provide a mechanism to tighten and loosen the grip of the pole clamp to remove the infuser from the IV pole. List Number: 20792-04-25; Serial Numbers: 17737372 ; 17737375 ; 17737377 ; 17737378 ; 17737383 ; 17737385 ; 17737390 ; 17737394 ; 17737395 ; 17737396 ; 17737397 ; 17737398 ; 17737399 ; 17737400 ; 17737402 ; 17737405 ; 17737408 ; 17737409 ; 17737414 ; 17737416 ; 17737419 ; 17737420 ; 17737421 ; 17737422 ; 17737424 ; 17737425 ; 17737426 ; 17737429 ; 17737430 ; 17737431 ; 17737432 ; 17737433 ; 17737435 ; 17737438 ; 17737440 ; 17737442 ; 17737443 ; 17737444 ; 17737445 ; 17737446 ; 17737447 ; 17737448 ; 17737449 ; 17737450 ; 17737451 ; 17737452 ; 17737454 ; 17737456 ; 17737458 ; 17737459 ; 17737460 ; 17737462 ; 17737463 ; 17737464 ; 17737467 ; 17737470 ; 17737475 ; 17737476 ; 17737478 ; 17737479 ; 17737480 ; 17737483 ; 17737485 ; 17737486 ; 17737489 ; 17737490 ; 17737492 ; 17737498 ; 17737500 ; 17737501 ; 17737502 ; 17737506 ; 17737507 ; 17737508 ; 17737511 ; 17737514 ; 17737516 ; 17737518 ; 17737520 ; 17737521 ; 17737522 ; 17737524 ; 17737525 ; 17737526 ; 17737531 ; 17737533 ; 17737535 ; 17737539 ; 17737542 ; 17737545 ; 17737546 ; 17737550 ; 17737551 ; 17737556 ; 17737557 ; 17737558 ; 17737559 ; 17737560 ; 17737562 ; 17737564 ; 17737569 ; 17737575 Class II Plum A+ infusion system pole clamp assemblies were discovered to be cracked. If the knob on the pole clamp assembly is cracked, the infuser cannot be attached to the IV pole since the knob is used to tighten and loosen the grip of the pole clamp to the pole. Hospira Inc.
Devices Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature. Model Number(s): 100515-63 100510-63 100514-63 100512-63 100511-63 101200-03 100201-03 101202-03 101204-03 101205-03 101200-53 101202-53 101205-53 101200-02 101200-57 101201-57 101202-57 101204-57 101205-57 101200-63 101201-63 101202-63 101204-63 101205-63 101206-63 Class II Calibration factors in the pump overwritten during a programming step. The force sensor could send a lower signal value to the pump processor, with loss of prime warnings, occlusion alarms and the pump unable to detect a cartridge during the prime sequence. Field action initiated 8/29/2011. Animas Corporation
Drugs 1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02. Lot number: 31-427-DK, Exp 01JUL2015. Class I Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution. Hospira Inc.
Devices G- Series Beds; G29 full length bed rails assembly Model G5510 Date codes: 40121 40122 40130 40131 40201 40204 40205 40206 40210 40211 40212 40213 40214 40217 40218 40219 40220 40221 40224 40225 40226 40227 40228 40303 40304 40305 40306 40307 40310 40311 40312 40313 40314 40319 40325 40326 40327 40331 40401 40402 40403 40404 40410 40411 40414 40415 40416 40421 40422 40423 40424 40425 40429 40429 40430 40501 40502 40506 40507 40508 40512 40513 40514 40515 40516 40519 40520 40521 40522 40523 40526 40527 40528 40529 40530 40603 40604 40605 40606 40610 40611 40612 40613 40616 40617 40618 40619 40620 40623 40624 40625 40626 40627 40630 40701 40702 40703 40707 40708 40709 40714 40715 40716 40717 40721 40722 40723 40724 40728 40729 40730 40731 40805 40806 40807 40811 40812 40813 40818 40819 40820 40825 40826 40901 40902 40904 Class II Invacare identified that the rail mounting bracket on the G29 full length bed rail was out of specification for entrapment safety. Invacare Corporation
Devices DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT. This assay provides only a preliminary analytical test result. PC 09077, PC03227, PC03055, PC09293, PC11115, PC08126, PC06276, PC07085, PC06305, and PC08017. Class II This recall has been initiated due to potential false positives results when using the test to screen for Ketamine. Use of this product may give incorrect screening results. Express Diagnostics Int'l., Inc.
Devices SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory. 4.0.7.0: released 12/13/13 - present 4.0.7.1: released 02/28/14 - present Class II The interface fails to send abnormal flags for Reference Lab test results. SCC Soft Computer
Devices Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer Model/Catalog/Part #: 1. cobas b221 <6>=Roche OMNI S6 SYSTEM; and 2. 03337154692 - cobas b 221<6>=Roche OMNI S6 SYSTEM CU Potassium - CEM, Calcium - JFP, Sodium - JGS, Chloride - CGZ, Blood Gases (PCO2, PO2) and pH - CHL, Hemoglobin -GKR, Hematocrit - GKF, Oxygen saturation, Carboxyhemoglobin - GHS, Oxyhemoglobin -  ...
More
Class II Chemical component of the F3 Fluid pack and environmental bacterial contamination causes a positive bias up to 39% at 4.1 mmol/l for the glucose measurement and 30% at 4.12 mmol/l for lactate. Urea readings are unaffected. Roche Diagnostics Operations, Inc.
Food Bleating Heart Cheese, Ewelicious Blue, Sheep Milk Blue Cheese Handcrafted with whimsy in California; Ingredients: Raw sheep milk, salt, cultures, rennet. Aged 2 months or more. All product produced between February 14, 2014 (coded 14-0214) and September 19, 2014 (coded 14-0919). Class I FDA samples found the presence of Listeria Monocytogenes in three varieties of cheese. Bleating Heart Cheese LLC
Food Bleating Heart Cheese, Fat Bottom Girl Curvacious Sheep Milk Cheese Handcrafted with whimsy in California; Ingredients: Raw sheep milk, salt, cultures, rennet. Aged 2 months or more. All product produced between February 14, 2014 (coded 14-0214) and September 19, 2014 (coded 14-0919). Class I FDA samples found the presence of Listeria Monocytogenes in three varieties of cheese. Bleating Heart Cheese LLC
Food Bleating Heart Cheese, Goldette Tommette Semi Firm Jersey Milk Cheese Handcrafted with whimsy in California; Semi Firm Jersey Milk Cheese Ingredients: Raw jersey cow milk, salt, cultures, rennet. Aged 2 months or more. All product produced between February 14, 2014 (coded 14-0214) and September 19, 2014 (coded 14-0919). Class I FDA samples found the presence of Listeria Monocytogenes in three varieties of cheese. Bleating Heart Cheese LLC
Food Bleating Heart Cheese, Buff Blue; Water Buffalo milk Blue Cheese Handcrafted with whimsy in California; Ingredients: Raw water buffalo milk, salt, cultures, rennet. Aged 2 months or more. All product produced between February 14, 2014 (coded 14-0214) and September 19, 2014 (coded 14-0919). Class I FDA samples found the presence of Listeria Monocytogenes in three varieties of cheese. Bleating Heart Cheese LLC
Food Bleating Heart Cheese, Double Down Blue - Mixed Milk Blue Cheese. Handcrafted with whimsy in California; Ingredients: Raw Jersey cow and sheep milk, salt, cultures, rennet. Aged 2 months or more. All product produced between February 14, 2014 (coded 14-0214) and September 19, 2014 (coded 14-0919). Class I FDA samples found the presence of Listeria Monocytogenes in three varieties of cheese. Bleating Heart Cheese LLC
Food Bleating Heart Cheese, Buff Ewe Blue - Sheep and Buffalo milk blue cheese. Handcrafted with whimsy in California; Ingredients: Raw sheep and water buffalo milk, salt, cultures, rennet. Aged 2 months or more. All product produced between February 14, 2014 (coded 14-0214) and September 19, 2014 (coded 14-0919). Class I FDA samples found the presence of Listeria Monocytogenes in three varieties of cheese. Bleating Heart Cheese LLC
Food Bleating Heart Cheese, Funky Bleats - Mixed milk cheese with funk. Handcrafted with whimsy in California; Ingredients: Raw sheep and goat milk, salt, cultures, rennet. Aged 2 months or more. All product produced between February 14, 2014 (coded 14-0214) and September 19, 2014 (coded 14-0919). Class I FDA samples found the presence of Listeria Monocytogenes in three varieties of cheese. Bleating Heart Cheese LLC
Food Bleating Heart Cheese, Mixtress - Mixed milk natural rind cheese. Handcrafted with whimsy in California; Ingredients: Raw sheep milk, raw jersey cow milk, salt, cultures, rennet. Aged 2 months or more. All product produced between February 14, 2014 (coded 14-0214) and September 19, 2014 (coded 14-0919). Class I FDA samples found the presence of Listeria Monocytogenes in three varieties of cheese. Bleating Heart Cheese LLC
Food Bleating Heart Cheese, Moolicious Blue - Natural rind blue cheese. Handcrafted with whimsy in California; Ingredients: Raw water buffalo milk, salt, cultures, rennet. Aged 2 months or more. All product produced between February 14, 2014 (coded 14-0214) and September 19, 2014 (coded 14-0919). Class I FDA samples found the presence of Listeria Monocytogenes in three varieties of cheese. Bleating Heart Cheese LLC
Food Bleating Heart Cheese, Shepherdista - Natural rind sheep milk cheese. Handcrafted with whimsy in California; Ingredients: Raw water buffalo milk, salt, cultures, rennet. Aged 2 months or more. All product produced between February 14, 2014 (coded 14-0214) and September 19, 2014 (coded 14-0919). Class I FDA samples found the presence of Listeria Monocytogenes in three varieties of cheese. Bleating Heart Cheese LLC
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W051514089498; W051514089498; W051514035824; W051514035824 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. Innovative Blood Resources
Biologics Red Blood Cells Leukocytes Reduced W051514079525; W051514025551 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. Innovative Blood Resources
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W051514100893; W051514100893; W051514053997; W051514024458 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Innovative Blood Resources
Biologics Platelets Pheresis Leukocytes Reduced W051514112264; W051514112264; W051514106157; W051514106157; W051514076846; W051514076846; W051514053997; W051514045213; W051514039857; W051514039857; W051514024458 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Innovative Blood Resources
Biologics Red Blood Cells Leukocytes Reduced W051514100847 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Innovative Blood Resources
Devices Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT612010V01, and BVT612030V01. Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. Model BVT608010, Lot numbers: 9853174, 9864497, 9890772, 9890931, 9925676, 9932672, 9937308, 9937315, 9940474, 9940614, 9976340, 9978233, A001589, A001740. Model BVT608030, Lot Numbers: 9853331, 9887597, 9887695, 9887757, 9932042. Model BVT612010, Lot numbers: 9854121, 9868214, 9868311, 9875472, 9875632, 9876174, 9883295, 9884788, 9884951, 9886196, 9886312, 9932096, 9968511, 9974109, 9974126, 9976472, 9977091, 9978862, A002299,  ...
More
Class I A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port identification on the units. Units have been identified to have the distal balloon inflation port incorrectly labeled as proximal, and, the proximal balloon port incorrectly labeled as distal. Covidien
Devices Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. Model CVT808015, Lot numbers: 9895996, 9904675, 9910270, 9911926, 9912084, 9912200, 9922490, 9922584, 9922597, 9922601, 9922604, 9922606, 9922617, 9922620, 9922624, 9922635, 9923420, 9924840, 9928078, 9932274, 9933341, 9933774, 9933839, 9933934, 9934029, 9934440, 9934633, 9934686, 9936420, 9937544, 9937660, 9942679, 9943032, 9945436, 9948145, 9949409, 9950000, 9950703. Model CVT808025, Lot numbers: 9904237, 9906429, 9910270, 9912003,  ...
More
Class I A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port identification on the units. Units have been identified to have the distal balloon inflation port incorrectly labeled as proximal, and, the proximal balloon port incorrectly labeled as distal. Covidien
Devices Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage: The recall device is indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD Systems in clinical and home use settings. H13L22013 Class II Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage. Baxter Healthcare Corp.
Biologics Red Blood Cells Leukocytes Reduced W043214065413; W043214045673 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. Blood Assurance Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W071214010749; W071214010749 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. Medic Inc
Devices BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40 mm), not for skin injection; Catalog #305064 BD 10 mL Syringe Luer-Lok Tip with BD Precision Glide Needle 20G x 1 (0.9mm x 25mm); Catalog #305064 Product Usage: 1) BD Blunt Plastic Cannula is used to penetrate pre-slit septums covering injection sites, as well as vials designed for penetration with needless IV access cannula. 2) The blunt steel canula will be targeted for exiting applications of pointer cannula, where blunt steel cannula would provide increased safety. Such existing applications include: -Accessing pre-slit/pre-pierced IV septum ports -Providing for fluid transfer -Can be used as tubing adapter 3) The BD single use Hypodermic Syringe is intended for use by healthcare professional for general purpose fluid aspiration/injection. Catalog #303348, Lot #4209518; Catalog #305064, Lot #4205576; Catalog #309644 Lot #4209524 Class II The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe. Becton Dickinson & Company
Food CARROLL SHELBY'S ORIGINAL TEXAS BRAND CHILI KIT, NET WT. 4 oz. (113 g), Dist. by Reily Foods Company, New Orleans, LA 70130, 1-800-535-1961, UPC 0-00-72396-10000-8 Best by: July 1, 2016 - Nov 21, 2016 Class I Kits contain peanut and almond allergens that are not declared on the products' ingredient statements. Reily Foods Co.
Food CARROLL SHELBY'S ORIGINAL TEXAS BRAND WHITE CHICKEN CHILI KIT, 3 oz. (85 g), Dist. by Reily Foods Company, New Orleans, LA 70130, UPC 0-00-72396-10019-0 Best by: July 1, 2016 - Dec 08, 2016 Class I Kits contain peanut and almond allergens that are not declared on the products' ingredient statements. Reily Foods Co.
Food WICK FOWLER'S FAMOUS TEXAS STYLE 2-ALARM Chili Kit, NET WT. 3.6525 oz. (102g), Dist. by Reily Foods Company, New Orleans, LA 70130, 1-800-535-1961, UPC 0-00-71092-00069-8 Best by: July 1, 2016 - Dec 08, 2016 Class I Kits contain peanut and almond allergens that are not declared on the products' ingredient statements. Reily Foods Co.
Food WICK FOWLER'S TEXAS STYLE FALSE ALARM Mild Chili Kit, NET WT. 3.03 oz. (86g), Dist. by Reily Foods Company, New Orleans, LA 70130, UPC 0-00-71092-00111-4 Best by: Sept 02, 2016 - Dec 02, 2016 Class I Kits contain peanut and almond allergens that are not declared on the products' ingredient statements. Reily Foods Co.
Devices Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the patients prepared acetabulum and a linger (polyethylene or alumina ceramic) is then locked into the shell. The femoral head component of the total hip system articulates with the acetabular liner. 510K 983382 Lot code 49073501 Class II Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present. Stryker Howmedica Osteonics Corp.
Devices ABL90 FLEX analyzer, Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. Model number 393-090 (instrument). The affected analyzers are serial numbers 393-090R0027N001 to present. Class II The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can in some cases lead to a biased patient result. Radiometer America Inc
Devices Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic). Item No. 42-5299-001-00 Affected Lots: 56572679; 56573170; 56574318; 56575056; 56572918; 56573378; 56574538; 56575057; 56572975; 56573379; 56574540; 56575058; 56572978; 56574123; 56574618; 56575059; 56572981; 56574124; 56574619; 56575060; 56572982; 56574223; 56574620; 56575061; 56573071; 56574291; 56574629; 56575062; 56573115; 56574292; 56574630; 56575065; 56573116; 56574316; 56574631; 56575080; 56573154; 56574317; 56575018 Class II Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x 3.5mm in size. Retained tip may result in: pain, soft tissue irritation, soft tissue damage, or increased wear due to contact with the fractured tip; Revision surgery to remove the fractured tip Zimmer, Inc.
Devices LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON KDS-2, MEVATRON KD-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON M2 6300, MEVATRON MDX-2, MEVATRON MD-2; The intended use of the MEVATRON, PRIMUS, ONCOR and ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. Product Usage: The intended use of the MEVATRON, PRIMUS, ONCOR and ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. model numbers: 08139789, 05863472, 05857912, 07360717, 05857920, 04504200, 01940035, 05500371, 09822685, 09411588, 09822693, 08515520, 01940753, 01924500, 09401506, 09401407, 09401316, 09401746, 09401654, with serial numbers: 3397 3986 5087 70-4119 70-4144 70-4262 70-4343 4078 5120 5170 5282 5506 70-4146 5527 2958 3855 5517 3753 3702 3751 2863 3695 5364 3904 70-4287 70-4175 3102 3781 3203 5060 3798 70-4316 5205 3383 5688 5743 3832 2972 3942 70-4122 4067 70-4283 5190 5157 2646 5343 5844 3953 5148 5391 3931 5300 3802 70-4172 70-4143 70-4296 3079 2516 70-4235 2962 70-4257 5474 2834 70-4363 70-4368 3791 3793 3738 3817 3055 5833 5899 2586 5207 3458 3673 70-4378 5355 3515 70-4159 3524 3574 3519 5281 5894 5374 5558 3225 3631 3835 3367 3296 2702 3591 3267 2912 3905 3922 3924 2896 2814 3773 3679 3533 3709 5367 3618 70-4354 70-4356 5540 3103 5488 3859 3009 4019 5523 5590 5657 3624 2887 5350 5784 2974 5821 3503 70-4344 3285 3979 3541 3413 3774 2996 2125 5843 3504 3318 2628 70-4129 5851 3354 70-4183 3888 3066 3361 5098 3756 5385 2689 3305 2228 3604 3629 3136 5114 3748 3788 5700 2183 5410 2644 70-4323 3666 3825 2507 3241 70-4207 3987 4036 3989 5865 70-4166 3617 3736 5118 5548 3075 3769 2845 3842 5861 70-4188 5748 5222 3013 3484 3302 3068 70-4317 5737 5830 2596 5656 5245 5092 3303 3778 5088 4021 3245 5665 3815 3133 5823 3846 70-4178 2532 3907 70-4174 3534 5353 3826 3025 5630 70-4185 3639 3274 3664 2527 3761 5096 3801 3949 3878 3049 2894 5572 3699 3873 5417 4059 3805 5500 2965 5388 3547 2045 3116 3678 3186 70-4362 70-4379 5226 3623 3804 3453 3602 70-4142 2827 3657 3948 70-4135 3755 3754 5601 5640 3153 3622 5033 3514 5177 3084 3731 2855 4065 3147 5707 5398 4091 3644 4018 2906 5532 70-4306 70-4161 3114 3667 5424 3565 5755 3711 5326 5525 5145 3016 5699 4079 4082 70-4113 4015 3981 5419 3998 3975 5093 3479 5481 5396 70-4347 5008 2067 2818 3939 3089 5095 3901 5153 3244 5179 2244 5154 Class II A hardware update to replace the old PCB Assembly, Head Driver-G41 with one that is improved with overcurrent protection has been initiated for Linear Accelerators as a result of reports of the electric board inside the gantry showing signs of overheating, including thermal damage and smoke emission. Siemens Medical Solutions USA, Inc
Devices Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions. Lot Numbers: 1412001, 1412002, 1412003 and 1412004 Class II This recall has been initiated because use of the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment. The magnitude of error for VO2 or VCO2 parameters could be approximately 20% with use of the impacted product. Shape Medical Systems, Inc
Food Banana ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Banana Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Banana Split ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Banana Split Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Blackberry Cheesecake ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Blackberry Cheesecake Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Cappuccino Chip ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Cappuccino Chip Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Chocolate ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Chocolate Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Coffee ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Coffee Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Dollar Mint ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Dollar Mint Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food French Orange ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I French Orange Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Husky Flake ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Husky Flake ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Kona Koka Rum ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Kona Koka Rum Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Licorice ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Licorice Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Maple Walnut ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Maple Walnut Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Peppermint ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Peppermint Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Root Beer ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Root Beer Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Red Raspberry Ribbon ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Red Raspberry Ribbon Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Strawberry ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Strawberry Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Strawberry Cheesecake ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Strawberry Cheesecake Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Thin Mint ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Thin Mint Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Vanilla ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Vanilla Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Mocha ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Mocha Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Butter Toasted Pecan ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Butter Toasted Pecan Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Caramel Pecan Fudge ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Caramel Pecan Fudge Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Chocolate Fudge ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Chocolate Fudge Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Chocolate Chip Cookie Dough ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Chocolate Chip Cookie Dough Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Coconut ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Coconut Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Nutella ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Nutella Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Macadamia Nut ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Macadamia Nut Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Mocha Almond Fudge ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Mocha Almond Fudge Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Oreo Cookie ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Oreo Cookie Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Pralines and Cream ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Pralines and Cream Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Raspberry Decadence ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Raspberry Decadence Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Reese's Peanut Butter ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Reese's Peanut Butter Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Rocky Road ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Rocky Road Husky ice cream flavor is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Rum Truffle ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Rum Truffle Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Spumoni ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Spumoni Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Strawberry Grand Marnier ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Strawberry Grand Marnier Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Swiss Chocolate Orange ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Swiss Chocolate Orange Husky ice cream flavor is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Coffee Oreo ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Coffee Oreo Husky ice cream flavor is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Caramel Swirl ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Caramel Swirl Husky ice cream flavor is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Almond Joy ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Almond Joy Husky ice cream flavor is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Chocolate Fudge Brownie ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Chocolate Fudge Brownie Husky ice cream flavor is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Oreo Mint ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Oreo Mint Husky ice cream flavor is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Lemon Custard ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Lemon Custard Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Stout ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK POWDER, SUGAR, CORN SYRUP SOLIDS, CAROB BEAN GUM, GUAR GUM, SOY LECITHIN, CARRAGEENAN". No UPC code. Production date is hand-written on 2.5 gallon bulk containers. Class I Stout Husky ice cream is being recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains an ice cream mix ingredient manufactured and recalled by Snoqualmie Gourmet Ice Cream, Inc. Husky Ice Cream,Inc
Food Dried Bean Curd Satay Flavor, 24x150g, Item No. 8533. Batch No. GFC41540J, GFC41694K, GFC41827L, GFC42145M Class II Gemini Foods is recalling bean curd products because they may be contaminated with dimethyl yellow. Gemini Food Corporation Inc
Food Dried Bean Curd Anka Flavor 24x150g, Item No. 8535 Batch No. GFC4169K, GFC41827L, GFC42145M Class II Gemini Foods is recalling bean curd products because they may be contaminated with dimethyl yellow. Gemini Food Corporation Inc
Food Dried Bean Curd Chili Flavor 24x150g, Item No. 8536 Batch No. GFC41540J, GFC41694K, GFC41827L, GFC42145M Class II Gemini Foods is recalling bean curd products because they may be contaminated with dimethyl yellow. Gemini Food Corporation Inc
Food Dried Bean Curd Spicy Flavor 24x150g, Item No. 8537 Batch No. GFC41540J, GFC41694K, GFC41827L, GFC42145M, GFC42498N Class II Gemini Foods is recalling bean curd products because they may be contaminated with dimethyl yellow. Gemini Food Corporation Inc
Food Dried Bean Curd Garlic Flavor 24x150g, Item No. 8534 Batch No. GFC41540J, GFC4169K, GFC41827L, GFC42145M Class II Gemini Foods is recalling bean curd products because they may be contaminated with dimethyl yellow. Gemini Food Corporation Inc
Devices da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. PN 410298-05, -06, -07, -08, -09 Class II The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inconsistent with the User Manual Adendum (PN 550986-07_B) with regards to neceassary sterilization dry time. Intuitive Surgical, Inc.
Food Hummus; All-natural ZILKS FAMOUS ORIGINAL HUMMUS GLUTEN FREE & NON-GMO NET WT. 8 OZ Use by dates: 1/5/2015, 1/11/2015, 1/19/2015, 1/26/2015, 2/2/2015, 2/8/2015 Class II Potential undeclared peanuts in cumin ingredient. Zilks Foods
Food Hummus; All-natural ZILKS ROASTED RED PEPPER HUMMUS GLUTEN FREE & NON-GMO NET WT. 8 OZ Use by dates: 1/5/2015, 1/11/2015, 1/19/2015, 1/26/2015, 2/2/2015, 2/8/2015 Class II Potential undeclared peanuts in cumin ingredient. Zilks Foods
Food Hummus; All-natural ZILKS JALAPENO & CILANTRO HUMMUS GLUTEN FREE & NON-GMO NET WT. 8 OZ Use by dates: 1/6/2015, 1/12/2015, 1/20/2015, 1/27/2015, 2/2/2015, 2/9/2015 Class II Potential undeclared peanuts in cumin ingredient. Zilks Foods
Food Hummus; All-natural ZILKS BALSAMIC & GARLIC HUMMUS GLUTEN FREE & NON-GMO NET WT. 8 OZ Use by dates: 1/5/2015, 1/11/2015, 1/19/2015, 1/26/2015, 2/3/2015, 2/9/2015 Class II Potential undeclared peanuts in cumin ingredient. Zilks Foods
Food Hummus; All-natural ZILKS HATCH GREEN CHILI HUMMUS GLUTEN FREE & NON-GMO NET WT. 8 OZ Use by dates: 1/6/2015, 1/12/2015, 1/20/2015, 1/27/2015, 2/8/2015 Class II Potential undeclared peanuts in cumin ingredient. Zilks Foods
Food Hummus; All-natural ZILKS SPINACH & ARTICHOKE HUMMUS GLUTEN FREE & NON-GMO NET WT. 8 OZ Use by dates: 1/7/2015, 1/12/2015, 1/20/2015, 1/27/2015, 2/3/2015 Class II Potential undeclared peanuts in cumin ingredient. Zilks Foods
Food Hummus; All-natural ZILKS HUMMUS with REAL BACON GLUTEN FREE & NON-GMO NET WT. 8 OZ Use by dates: 1/6/2015, 1/12/2015, 1/21/2015, 1/27/2015, 2/3/2015, 2/9/2015 Class II Potential undeclared peanuts in cumin ingredient. Zilks Foods
Drugs Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24 Hour Non-Drowsy Allergy Relief Sugar Free, 4 FL OZ (120 mL) Bottles, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC: 51672-2092-8. Lot #: A4105, Exp 12/2016 Class II Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup. Taro Pharmaceuticals U.S.A., Inc.
Devices 16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1 Serial Numbers: H38309606702, H38309606704, H38309610105, H38309610104, H38309606701, H38309606703, H38309606705, H38309610101. Class II Customer complaint indicating the color bands on the MIA16-G1 were not correct. The Anspach Effort, Inc.
Devices Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is used in surgical or medical emergency facilities. Primarily used on infants and pediatric patients. Material Number: ISL6; Lot Numbers: 1409LS45A-SH, 1408LS41A-SH, 1406LS22A-SH, 1404LS14A-SH, 1310LS23A-SH, 1310LS21A-SH, 1308LS17A-SH, 1307LS14A-SH, 1303LS04A-SH, 1204LS03A-SH, 1110LS10A-SH, 1111LS11A-SH, 1107LS07A-SH, 1106LS06A-SH, 1104LS04A-SH, 1105LS05A-SH, 1003020386-SH, 912022138-SH, 910021815-SH, 907021095-SH Class II A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube. Cardinal Health
Food High Road Craft Ice Cream & Sorbet, Limoncello Sorbet, packed in 4.9L (1.3 gallon) tubs, Manufactured by: High Road Craft Ice Cream & Sorbet, Inc., 2241 Perimeter Park dr. Atlanta, GA 30341 (for restaurant use only). Best By Dates: 12/29/2015, 12/4/2015, 11/29/2015, 11/17/2015, 11/12/2015, 10/8/2015 Class I Undeclared Allergen; Milk High Road Craft Ice Cream, Inc.
Cosmetics AM Resorts Dreams Conditioning Shampoo, 4.0 oz.; Item No. B9500CS040 Batch Numbers 1320410798 & 1320410603; Lot #1307 Class II Product may be contaminated with Psuedomonas aeruginosa and Enterobacter gergoviae. Gilchrist & Soames
Cosmetics Destinations Conditioning Shampoo, 2.0 oz.; Item No.B6013CS020 Batch No. 1320411346; Lot #1308 Class II Product may be contaminated with Psuedomonas aeruginosa and Enterobacter gergoviae. Gilchrist & Soames
Cosmetics Neil George Body Wash, 50 ml; Item No.B2800BW50ML Batch No. 1314907424; Lot #1307 Class II Product may be contaminated with Psuedomonas aeruginosa and Enterobacter gergoviae. Gilchrist & Soames
Cosmetics Chamomile Mineral Bath, 2.0 oz.; Item No.B050MB020; Batch No. 1320607414; Lot #1308 Class II Product may be contaminated with Psuedomonas aeruginosa and Enterobacter gergoviae. Gilchrist & Soames
Cosmetics Thymes NAIA Shower Gel, 1.5 oz, and 128 oz.; Item No.B7625SG015 and Item No. B7625SG128 1.5 oz.- Batch No. 1321110467& 1321110711, ; Lot #1308 128 oz.- Batch No. 1321110711; Lot No. 1308 Class II Product may be contaminated with Psuedomonas aeruginosa and Enterobacter gergoviae. Gilchrist & Soames
Cosmetics Thymes NAIA Shower Gel, 1.5 oz, and 128 oz.; Item No.B7625SG015 and Item No. B7625SG128 1.5 oz.- Batch No. 1321110467& 1321110711, ; Lot #1308 128 oz.- Batch No. 1321110711; Lot No. 1308 Class II Product may be contaminated with Psuedomonas aeruginosa and Enterobacter gergoviae. Gilchrist & Soames
Cosmetics London Shower Gel, 1.5 oz; Item No.B200SG015 1.5 oz.- Batch No. 1322707388 ; Lot #1308 Class II Product may be contaminated with Psuedomonas aeruginosa and Enterobacter gergoviae. Gilchrist & Soames
Biologics Red Blood Cells Leukocytes Reduced W141414017063 Class III Blood product, collected from a donor with Polycythemia, was distributed. Meek Blood Center
Devices MobileDiagnost wDR motorized portable diagnostic X-ray systems. Serial Numbers: 12000166 , 13000046 , 13000047 , 13000048 , 13000049 , 13000053 , 13000054 , 13000055 , 13000056 , 13000057 , 13000058 , 13000060 , 13000064 , 13000070 , 13000071 , 13000071 , 13000075 , 13000077 , 13000078 , 13000079 , 13000085 , 13000090 , 13000092 , 13000093 ,  ...
More
Class II Reports of unexpected movement. Sedecal S.A.
Devices MobileDiagnost wDR motorized portable diagnostic X-ray systems. Serial Numbers: 12000166 , 13000046 , 13000047 , 13000048 , 13000049 , 13000053 , 13000054 , 13000055 , 13000056 , 13000057 , 13000058 , 13000060 , 13000064 , 13000070 , 13000071 , 13000071 , 13000075 , 13000077 , 13000078 , 13000079 , 13000085 , 13000090 , 13000092 , 13000093 , 13000094 , 13000109 , 13000117 , 13000127 , 13000139 , 13000140 , 13000141 , 13000142 , 13000143 , 13000144 , 13000145 , 13000158 , 13000167 , 13000168 , 13000169 , 13000196 , 13000199 , 13000200 , 13000201 , 13000202 , 13000203 , 13000204 , 13000205 , 14000004 , 14000005 , 14000006 , 14000008 , 14000009 , 14000010 , 14000011 , 14000013 , 14000014 , 14000015 , 14000016 , 14000017 , 14000019 , 14000024 , 14000026 , 14000029 , 14000031 , 14000032 , 14000033 , 14000034 , 14000037 , 14000038 , 14000041 , 14000043 , 14000046 , 14000047 , 14000048 , 14000049 , 14000050 , 14000051 , 14000052 , 14000069 , 14000072 , 14000075 , 14000077 , 14000078 , 14000079 , 14000080 , 14000081 , 14000082 , 14000083 , 14000084 , 14000085 , 14000086 , 14000087 , 14000088 , 14000089 , 14000103 , 14000106 , 14000109 , 14000112 , 14000116 , 13000163, 13000165, 13000177, 14000022, 14000028, 485059/SN11000013 , 485060/SN11000015 , 485061/SN11000012 , 485062/SN11000009 , 488169/SN11000011 , 488171/SN11000068 , 489088/SN11000040 , 489089/SN11000016 , 489616/SN11000033 , 489694/SN11000035 , 489695/SN11000036 , 489696/SN11000037 , 490027/SN11000034 , 490221/SN11000039 , 492417/SN11000048 , 493364/SN12000022 , 493462/SN12000023 , 493565/SN11000048 , 493566/SN11000047 , 494060/SN11000070 , 494061/SN11000071 , 494062/SN11000072 , 494063/SN11000073 , 494064/SN11000074 , 494065/SN11000075 , 494456/SN11000055 , 494464/SN11000065 , 494864/SN11000060 , 494865/SN11000056 , 494866/SN11000062 , 494867/SN11000051 , 495286/SN11000061 , 495938/SN12000007 , 495939/SN12000008 , 496387/SN12000003 , 496401/SN12000059 , 496446/SN11000082 , 497572/SN12000112 , 497715/SN11000080 , 500466/SN12000045 , 500467/SN12000060 , 500468/SN12000058 , 501028/SN12000026 , 502025/SN12000124 , 502026/SN12000125 , 502424/SN12000034 , 502721/SN12000047 , 503141/SN12000038 , 503142/SN12000037 , 503143/SN12000036 , 503144/SN12000039 , 503380/SN12000044 , 503541/SN12000040 , 504450/SN12000064 , 505077/SN12000048 , 507607/SN12000054 , 507906/SN12000055 , 508342/SN12000057 , 508532/SN12000062 , 508699/SN12000088 , 508783/SN12000108 , 508838/SN12000061 , 509062/SN12000107 , 509633/SN12000069 , 509640/SN12000071 , 510607/SN12000072 , 512160/SN12000077 , 512887/SN12000085 , 512888/SN12000086 , 512890/SN12000087 , 512892/SN12000082 , 513477/SN12000080 , 513478/SN12000081 , 513848/SN12000084 , 514103/SN12000092 , 514104/SN12000091 , 514461/SN12000090 , 514462/SN12000089 , 516891/SN12000110 , 516896/SN12000111 , 518135/SN12000118 , 518342/SN12000119 , 518343/SN12000120 , 518344/SN12000121 , 518345/SN12000122 , 518346/SN12000123 , 519326/SN13000005 , 519387/SN13000012 , 519388/SN13000006 , 519434/SN13000014 , 519506/SN13000011 , 519511/SN13000010 , 519598/SN13000118 , 519599/SN13000119 , 519600/SN13000120 , 519762/SN13000018 , 519763/SN13000013 , 520251/SN13000016 , 520252/SN13000027 , 520253/SN13000017 , 520254/SN13000019 , 520255/SN13000020 , 520256/SN13000021 , 520413/SN13000023 , 520414/SN13000025 , 520415/SN13000026 , 520416/SN13000031 , 520417/SN13000033 , 520418/SN13000030 , 520422/SN13000028 , 522633/SN13000035 , 522944/SN13000037 , 523279/SN13000042 , 523349/SN13000043 , 13000067, 506626/SN12000051, 497570/SN11000066, 509718/SN12000068, 494941/SN11000052, 500740/SN12000028, 500739/SN12000027, SN11000007 , SN13000059 , SN13000059 , SN13000060 , SN13000061 , SN13000069 , SN13000072 , SN13000073 , SN13000074 , SN13000080 , SN13000082 , SN13000083 , SN13000084 , SN13000087 , SN130000 Class II Reports of unexpected movement. Sedecal S.A.
Devices Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It is suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator support, delivered invasively or noninvasively, to patients who require the following types of ventilator support: "Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask or nasal prongs) "Assist/ Control, SIMV or Spontaneous modes of ventilation. All Puritan Bennett 980 ventilators Class II Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds. Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Devices Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. Product Usage: The Persona TASPs are sterilizable instruments Intended for multiple uses. The TASP components are used to aid the surgeon in assessing the thickness of the articular surface required. The TASP construct is utilized while conducting a trial range of motion. The TASP consists of 3 parts: a TASP bottom, a TASP shim, and a TASP top. The shims come in varying thicknesses to allow trialing for specific Articular Surface implant thicknesses. Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and  ...
More
Class II Provisional Shims found with missing ball bearings. There is a potential for delay in surgery and/or a missing part to be left in the wound. Repeated cycles using sonic cleaning can break down the ball bearing retention feature (swage) on the shim. To prevent this from occurring, Persona Tibial Articular Surface Provisional shims must be manually cleaned and inspected per product insert, 87-6203-991-22. Zimmer, Inc.
Biologics Blood and Blood Products for Reprocessing W1151133714563 Class III Blood product, collected from a donor who was previously deferred for testing reactive for anti-HCV, was distributed. Lifesouth Community Blood Centers - Montgomery Region
Devices SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a SmartSite bag access port, a non-vented drip chamber, roller clamp, infusion pump segment, a male luer, and low sorbing tubing. Lot No. 12056016, 12057027, and 12107105. Class II CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues. CareFusion 303, Inc.
Devices Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume calculation during hemodialysis treatment. Serial Numbers: 1C31M140038 1C31M140040 1C31M140041 1C31M140042 1C31M140033 1C31M140034 1C31M140035 1C31M140030 1C31M140075 1C31M140031 1C31M140027 1C31M140054 1C31M140057 1C31M140060 1C31M140039 1C31M140056 1C32M140005, 1C32M140059, 1C32M140058, 1C32M140014, 1C32M140013, 1C32M140004, 1C32M140012, 1C32M140011, 1C32M140009, 1C32M140008, 1C32M140003, 1C32M140007, 1C32M140006, 1C32M140023, 1C32M140021, 1C32M140022, 1C32M140020, 1C31M140073, 1C31M140050 Class II Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope Fresenius Medical Care Holdings, Inc.
Food Chopped Twix, chopped candy bars pieces packaged in 5 lb plastic white film bags, 2 bags per case Lot 087031314. Use by 06/07/15. UPC 73171100870 Class I The firm's Chopped Twix candy may contain undeclared allergens: peanuts and eggs. Tarrier Foods Corp
Devices ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Model number 10433816. serial numbers 401100 to 401400. Class II The bolt holding the control panel of the ACUSON SC2000 in a fixed position may fail and the Control panel cannot be locked into position. Siemens Medical Solutions USA, Inc.
Devices FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928 (USB drive with FORUM 3.2.1). ophthalmic image management system. Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928 (USB drive with FORUM 3.2.1) Class II Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical coherence tomography (OCT) data. Carl Zeiss Meditec AG
Devices KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices. WI14H054 Class II The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two diamond-tipped instruments. Medtronic Sofamor Danek USA Inc
Show all Code Info
-
-