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U.S. Department of Health and Human Services

Enforcement Report - Week of March 9, 2016

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Veterinary Acetyl-D-Glucosamine 100 mL Vial (20%) in amber glass vials; For IM Injection Only, Rx. Lot: 04132015@41 BUD: 10/10/2015, 04222015@63 BUD: 10/19/2015, 07272015@62 BUD: 1/23/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Acth. Gel*R* (80 units/mL) and (40 units/mL) in 10 mL amber glass vials and 10 mL glass vials; For IM Use Only, Rx. Lot: 06162015@54 BUD: 9/14/2015, 06182015@39 BUD: 9/16/2015, 08062015@28 BUD: 11/4/2015, 09032015@2 BUD: 12/2/2015, 09082015@7 BUD: 12/7/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Adenosine Monophosphate (200 mg/mL) in 100 mL amber glass vials; For IM Use Only, Rx. Lot: 04152015@69 BUD: 10/12/2015, 05182015@45 BUD: 11/7/2015, 07172015@23 BUD: 1/13/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Amikacin PF 2 mL (250 mg/mL) in glass vials; For Intra-Articular, IM, or IV Use Only, Rx. Lot: 04032015@11 BUD: 9/30/2015, 05192015@7 BUD: 11/15/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Ammonium Chloride Sterile 10 mL Vial (5%) in glass vials; For IV Use After Dilution, Rx. Lot: 03182015@23 BUD: 9/14/2015, 04142015@7 BUD: 10/11/2015, 05072015@17 BUD: 11/3/2015, 06012015@60 BUD: 11/28/2015, 06162015@7 BUD: 12/13/2015, 06242015@64 BUD: 12/21/2015, 07132015@19 BUD: 1/9/2016, 07282015@125 BUD: 1/24/2016, 09012015@81 BUD: 2/28/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Ammonium Sulfate Sterile 100 mL Vial (0.75%) and (10%) in amber glass vials; For IV Use After Dilution, Rx. Lot: 03262015@26 BUD: 9/22/2015, 04032015@18 BUD: 9/30/2015, 04062015@28 BUD: 10/3/2015, 04302015@22 BUD: 10/27/2015, 05052015@15 BUD: 11/1/2015, 06102015@95 BUD: 12/7/2015, 06112015@28 BUD: 12/8/2015, 06162015@9 BUD: 12/13/2015, 07152015@27 BUD: 1/11/2016, 07222015@62 BUD: 1/18/2016, 08042015@74 BUD: 1/31/2016, 09012015@84 BUD: 2/28/2016, 09032015@17 BUD: 3/1/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Apomorphine 1 mL Vial (1 mg/mL) in 2 mL amber glass vial; Apomorphine 1 mL Vial (10 mg/mL) in 2 mL amber glass vial; Apomorphine 10 mL Vial (1 mg/mL) in 10 mL glass vial; Apomorphine 10 mL Vial (3 mg/mL) in 10 mL glass vial; Apomorphine 1 mL Vial (3 mg/mL) in 2 mL amber glass vial; Apomorphine Sterile 30 mL Vial (1 mg/mL) in 30 mL glass vials, For IV or IM Injection/For SC or IV Use, Rx. Lot:06192015@38 BUD: 9/17/2015, 08042015@32 BUD: 11/2/2015, 08102015@63 BUD: 11/8/2015, 09022015@66 BUD: 12/1/2015, 07082015@10 BUD: 10/6/2015, 07092015@30 BUD: 10/7/2015, 07202015@44 BUD: 10/18/2015, 06222015@53 BUD: 9/20/2015, 06302015@44 BUD: 9/28/2015, 07082015@19 BUD: 10/6/2015, 07202015@36 BUD: 10/18/2015, 07202015@37 BUD: 10/18/2015, 07272015@15 BUD: 10/25/2015, 07312015@26 BUD: 10/29/2015, 08072015@24 BUD: 11/5/2015, 08072015@35 BUD: 11/5/2015, 08312015@49 BUD:  ...
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Class II Lack of sterility assurance. US Compounding Inc
Veterinary Aspirin (100 mg/mL) in glass vials; For IV Use, Rx. Lot: 03242015@38 BUD: 9/20/2015, 05202015@66 BUD: 11/16/2015, 08032015@18 BUD: 1/30/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary ATP/B12/NA Selenite/Potassium ASP/Magnesium ASP (2/1/2/20/30 mg per mL) in 100 mL glass vials; For IV or IM Use Only, Rx. Lot: 08122015@15 BUD: 11/10/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Atropine/Phenylpropanolamine/Chlorpheniramine 10 mL Vial (0.2 mg/12.5 mg/5 mg/mL) in glass vials; For IM Use Only, Rx. Lot: 03242015@20 BUD: 9/20/2015, 04302015@33 BUD: 10/27/2015, 06252015@12 BUD: 12/22/2015, 07202015@47 BUD: 1/16/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary B12/B2/B6/B3/B5/Cu Gluc/CACO Sterile 250 mL bottle (0.3mg/14.7/10 mg/100 mg/15 mg/0.2 mg/6.4 mg/mL) in plastic bottles; For IM Use Only, Rx. Lot: 03232015@7 BUD: 9/19/2015, 04012015@11 BUD: 9/28/2015, 04292015@33 BUD: 10/26/2015, 07012015@87 BUD: 12/28/2015, 07062015@43 BUD: 1/2/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary B12/B2/B6/B3/B5/Cu Gluc/CACO/Dex Sterile 250 mL Bottle (0.3 mg/10.75 mg/10 mg/100 mg/15 mg/0.2 mg/6.4 mg/1 mg/mL) in plastic bottles; For IV Use After Dilution, Rx. Lot: 03172015@18 BUD: 9/13/2015, 04292015@13 BUD: 10/26/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Betamethasone Combo 5 mL in 10 mL Vial (7 mg/mL) in amber glass vials; For IM & Regional Injection, Rx. Lot: 06032015@60 BUD: 11/29/2015, 07092015@65 BUD: 1/4/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Bethanechol (5 mg/mL) in 100 mL amber glass vials; For IM or IV Use, Rx. Lot: 03262015@19 BUD: 9/22/2015, 05072015@21 BUD: 11/3/2015, 06152015@71 BUD: 12/12/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Budesonide/Gentamicin (3 mg/120 mg/25 mL) in 250 mL glass vials; For IM Use Only, Rx. Lot: 09032015@33 BUD: 11/2/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Buprenorphine HCl Sterile 100 mL Vial (0.6 mg/mL) in amber glass vials; Buprenorphine Sterile 10 mL (0.6 mg/mL) in glass vials; Buprenorphine Sterile 20 mL vial (0.6 mg/mL) in glass vials; Buprenorphine Sterile 30 mL Vial (0.6 mg/mL) in glass vials; Buprenorphine Sterile 50 mL Vial (0.6 mg/mL) in glass vials; Buprenorphine Sterile 5 mL Vial (0.6 mg/mL) in glass vials; Buprenorphine HCL Sterile 30 mL Vial (0.9 mg/mL) in glass vials; Buprenorphine Sterile 60 mL in 100 mL Vial (0.6 mg/mL) in glass vials; For IV or IM Use Only, Rx. Lot: 03232015@51 BUD: 9/19/2015, 04102015@20 BUD:10/7/2015, 04212015@53 BUD: 10/18/2015, 04102015@11 BUD: 10/7/2015, 05082015@24 BUD: 11/4/2015, 05212015@20 BUD: 11/17/2015, 06012015@26 BUD:  ...
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Class II Lack of sterility assurance. US Compounding Inc
Veterinary Buprenorphine PF 1 mL Syringe (0.3 mg/mL) in 3 mL syringes; For IV or IM Use Only, Rx. Lot: 04232015@2 BUD: 10/20/2015, 05212015@10 BUD: 11/17/2015, 06292015@4 BUD: 12/26/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary CACO CMPD 100 mL Vial (6.4 mg/1 mg/0.2 mg/mL) in amber glass vials; For IV or IM Use Only, Rx. Lot: 03182015@31 BUD: 9/14/2015, 04102015@21 BUD: 10/7/2015, 05122015@95 BUD: 11/8/2015, 06042015@76 BUD: 12/1/2015, 06152015@82 BUD: 12/12/2015, 06222015@31 BUD: 12/19/2015, 07012015@28 BUD: 12/28/2015, 07152015@12 BUD: 1/11/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary CACO/Ferric Cl/Cu Gluc./Strychnine Sterile 100 m: (6.4 mg/1 mg/0.2 mg/mL) in 100 mL amber glass vials; For IV or IM Use Only, Rx. Lot: 03162015@10 BUD: 9/12/2015, 04142015@27 BUD: 10/11/2015, 05182015@28 BUD: 11/14/2015, 05202015@3 BUD: 11/15/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary CACODYLATE Cmpd (w/ Strych 0.00348%) Sterile (6.4/1/0.2 mg/mL) in 100 mL amber glass vials; For IV or IM Use Only, Rx. Lot: 05062015@18 BUD: 10/5/2015, 05182015@32 BUD: 10/5/2015, 05202015@63 BUD: 10/5/2015, 06022015@64 BUD: 10/5/2015, 06052015@28 BUD: 10/5/2015, 06232015@24 BUD: 10/5/2015, 07212015@45 BUD: 10/5/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Camphor in Olive Oil (20%) in 100 mL glass vials; For IM Use Only, Rx. Lot: 03262015@32 BUD: 9/22/2015, 06042015@74 BUD: 12/1/2015, 07172015@30 BUD: 1/13/2016, 09032015@44 BUD: 3/1/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Chloral Hydrate Inj. Solution (1 gm/mL) in 20 mL glass vials; For IM Use Only, Rx. Lot: 08072015@36 BUD: 11/5/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Chloramphenicol Ointment 4 gm tube (1%) in metal tubes; For Topical Ophthalmic Use, Rx. Lot: 06292015@89 BUD: 9/27/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Cimetidine (150 mg/mL) in 100 mL glass vials; For IM Use Only, Rx. Lot: 07202015@24 BUD: 10/18/2015, 07282015@67 BUD: 10/26/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Ciprofloxacin Ophthalmic 4 gm tube (0.5%) in metal tubes; For Topical Ophthalmic Use, Rx. Lot: 04272015@10 BUD: 9/16/2015, 07012015@71 BUD: 12/1/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Cyclosporine (A) in oil 10 mL dropper (2%) in 15 mL dropper bottle, Cyclosporine (A) in oil 10 mL in 15 mL dropper (1%), Cyclosporine (A) in Oil 15 mL dropper (1%), Cyclosporine (A) in Oil 15 mL dropper (2%), Cyclosporine (A) in Oil 8 mL in 10 mL dropper (2%), Cyclosporine (A) in Oil in 8 mL in 10 mL dropper (1%), Cyclosporine (A) in Oil in 8 mL in 15 mL dropper (2%), Cyclosporine (A) in Oil in 8 mL in 15 mL dropper (1%); For Topical Ophthalmic Use, Rx. Lot: 05052015@57 BUD: 11/1/2015, 05052015@57 BUD: 11/1/2015, 06082015@52 BUD: 12/5/2015, 03192015@12 BUD: 9/15/2015, 04062015@12 BUD: 10/3/2015, 06162015@30 BUD: 12/13/2015, 03192015@20 BUD: 9/15/2015, 05052015@54 BUD: 11/1/2015, 05112015@24 BUD: 11/7/2015, 05052015@57 BUD: 11/1/2015, 05112015@24 BUD: 11/7/2015, 06152015@13 BUD: 12/12/2015, 06232015@76 BUD: 12/20/2015, 07072015@56 BUD: 1/3/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Cyclosporine Ointment 4 gm tube (2%) in metal tube, Cyclosporine Ointment 4 gm tube (1%) in metal tube; For Topical Ophthalmic Use, Rx. Lot: 06152015@54 BUD: 9/13/2015, 07152015@87 BUD: 10/13/2015, 07282015@123 BUD: 10/26/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Deslorelin & HCG Kit 10 mL Vial (15 mg/20,000 units) in amber glass vials; Deslorelin & HCG Kit 1 mL Vial (1.5 mg/2,000 units) in amber glass vials; Deslorelin & HCG Kit 2 mL Vial (1.5 mg/2,000 units) in amber glass vials; For IM Use Only, Rx. Lot: 06082015@45 BUD: 12/5/2015, 04062015@10 BUD: 10/3/2015, 04062015@10 BUD: 10/3/2015, 06222015@2 BUD: 12/19/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Deslorelin Kit 10 mL Vial (15 mg) in amber glass vials; For IM Use Only, Rx. Lot: 05042015@7 BUD: 10/31/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Desmopressin Acetate, Ophthalmic (0.1 mg/mL (10 mcg/0.1 mL) in 10 mL dropper bottle; For Topical Ophthalmic Use, Rx. Lot: 07162015@86 BUD: 10/14/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Detomidine HCl/Xylazine HCl Sterile 50 mL vial (10 mg/10 mg/mL) in glass vials; Detomidine HCl/Xylazine HCl Sterile 50 mL vial (20 mg/10 mg/mL) in amber glass vials; For IM or IV Use, Rx. Lot: 062602015@28 BUD: 9/24/2015, 062602015@50 BUD: 9/24/2015, 07292015@44 BUD: 10/3/2015, 07312015@22 BUD: 10/29/2015, 08102015@48 BUD: 11/8/2015, 09012015@87 BUD: 11/30/2015, 062602015@28 BUD: 9/24/2015, 062602015@50 BUD: 9/24/2015, 07292015@44 BUD: 10/27/2015, 07312015@22 BUD: 10/29/2015, 08102015@48 BUD: 11/8/2015, 09012015@87 BUD: 11/30/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Dexamethasone Sodium Phosphate 50 mL Vial (480 mg/mL) in amber glass vials; For IM or IV Use, Rx. Lot: 08032015@45 BUD: 1/30/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Diclofenac Sodium Ointment (0.1%) in 4 gm metal tube; For Topical Ophthalmic Use, Rx. Lot: 06292015@84 BUD: 9/27/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Diclofenac Sodium Solution (0.1%) in 10 mL dropper bottles; For Topical Ophthalmic Use, Rx. Lot: 07212015@25 BUD: 1/17/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Estradiol 17B (10 mg/mL) in 10 mL glass vials; For IM Use Only, Rx. Lot: 07012015@55 BUD: 9/29/2015, 07062015@49 BUD: 10/4/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Estradiol Cypionate Sterile 100 mL vial (2 mg/mL) in glass vials, Estradiol Cypionate Sterile 30 mL vial (5 mg/mL) in glass vials, Estradiol Cypionate Sterile 50 mL vial (2 mg/mL) (5 mg/mL) (10 mg/mL) in glass vials in glass vials; For IM Use Only, Rx. Lot: 06022015@83 BUD: 11/29/2015, 06052015@22 BUD: 12/2/2015, 08312015@57 BUD: 2/27/2016, 04152015@17 BUD: 10/12/2015, 04202015@63 BUD: 10/17/2015, 04212015@51 BUD: 10/18/2015, 06042015@20 BUD: 12/1/2015, 06192015@14 BUD: 12/16/2015, 07212015@70 BUD: 1/17/2016, 07272015@38 BUD: 12/2/2015, 07302015@20 BUD: 12/2/2015, 09042015@10 BUD: 2/28/2016, 09042015@26 BUD: 2/28/2016, Class II Lack of sterility assurance. US Compounding Inc
Veterinary Estrone AQ 100 mL Vial (5 mg/mL) in amber glass vials; Estrone AQ 30 mL Vial (5 mg/mL) in amber glass vials; For IM Use Only, Rx. Lot: 04292015@44 BUD: 10/26/2015, 06112015@10 BUD: 12/8/2015, 07092015@60 BUD: 1/5/2016, 07232015@43 BUD: 1/19/2016, 04292015@29 BUD: 10/26/2015, 06012015@49 BUD: 11/28/2015, 07132015@6 BUD: 1/9/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary FENH/B2/B6/B3/B5/Co Gluc./GU Gluc./Choline/CHL/Inositol/Methionine/Lysine/HCl/Glycine/Cyanocobalamin/Biotin (1.5 gm/1.075 gm/1 gm/10 gm/1.5 gm/0.07 gm) in 250 mL brown bottle; For IM or SC Injection, Rx. Lot: 03162015@4 BUD: 9/12/2015, 06092015@4 BUD: 12/6/2015, 07202015@10 BUD: 1/16/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Fluoxetine HCl*Sterile (32 mg/mL) in 50 mL glass vials; For Injection, Rx Lot: 07062015@57 BUD: 10/4/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Folic Acid (15 mg/mL) in 100 mL glass vials; Folic Acid Sterile 100 mL vial (10 mg) in glass vials; For IM or IV use, Rx. Lot: 05192015@38 BUD: 11/15/2015, 04222015@43 BUD: 10/19/2015, 05202015@62 BUD: 11/16/2015, 06022015@75 BUD: 11/29/2015, 06172015@23 BUD: 12/14/2015, 07142015@30 BUD: 1/10/2015, 09012015@1 BUD: 2/27/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Guaifenesin 1000 mL Bag (5%(50 mg/mL)) in 1000 mL IV Bags; Guaifenesin 500 mL bag (5%(50 mg/mL)); For IV Infusion or IV Injection, Rx. Lot: 03192015@37 BUD: 9/15/2015, 04152015@52 BUD: 10/12/2015, 05212015@63 BUD: 11/17/2015, 06042015@54 BUD: 12/1/2015, 06232015@91 BUD: 12/20/2015, 07222015@99 BUD: 1/18/2015, 04232015@28 BUD: 10/20/2015, 06292015@119 BUD: 12/26/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Guanabenz Acetate (2 mg/mL) in 50 mL glass vials; For IM Use Only, Rx. Lot: 05192015@77 BUD: 11/15/2015, 06022015@63 BUD: 11/15/2015, 07202015@31 BUD: 1/16/2016, 07292015@35 BUD: 1/25/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Idoxuridine Solution (0.1%) in 5 mL dropper bottle; For Topical Ophthalmic Use, Rx. Lot: 06252015@43 BUD: 9/23/2015, 08042015@58 BUD: 11/2/2015, 08122015@41 BUD: 11/10/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Ivermectin (2%) in 100 mL glass vials; For IM Use Only, Rx. Lot: 07272015@23 BUD: 10/25/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Ketoprofen 100 mL (10%) in amber glass vials; For IV or IM Injection, Rx. Lot: 05062015@52 BUD: 11/2/2015, 05202015@59 BUD: 11/16/2015, 06082015@47 BUD: 12/5/2015, 06242015@44 BUD: 12/21/2015, 07172015@33 BUD: 1/12/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary L-Arginine Sterile 100 mL Vial (200 mg/mL) in glass vials; L-Arginine Sterile 100 mL Vial (100 mg/mL) in glass vials; For IV Use, Rx. Lot: 03182015@29 BUD: 9/14/2015, 06302015@32 BUD: 12/27/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Magnesium Sulfate 100 mL vial (500 mg/mL (4 meq/mL) in amber glass vial; Magnesium Sulfate 250 mL (500 mg/mL (4 meq/mL) in amber glass vial; Magnesium Sulfate 500 mL (500 mg/mL (4 meq/mL) in amber glass vial; For IV or IM Injection, Rx. Lot: 05132015@12 BUD: 11/9/2015, 06102015@95 BUD: 12/7/2015, 04072015@7 BUD: 10/4/2015, 06292015@30 BUD: 12/26/2015, 04072015@9 BUD: 10/4/2015, 06092015@66 BUD: 12/6/2015, 06292015@53 BUD: 12/26/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Medroxyprogesterone 100 mL Vial (200 mg/mL) in amber glass vials; Medroxyprogesterone 100 mL Vial (100 mg/mL) in amber glass vials; Medroxyprogesterone 30 mL Vial (200 mg/mL) in amber glass vials; Medroxyprogesterone 30 mL Vial (100 mg/mL) in amber glass vials; For IM Use Only, Rx. Lot: 04162015@32 BUD: 10/13/2015, 05182015@85 BUD: 11/14/2015, 06022015@96 BUD: 11/29/2015, 06152015@65 BUD: 12/12/2015, 06152015@84 BUD: 12/12/2015, 04162015@28 BUD: 10/13/2015, 05072015@6 BUD: 11/1/2015, 06022015@82 BUD: 11/29/2015, 07152015@10 BUD: 1/10/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Meloxicam (10 mg/mL) in 10 mL glass vials; Meloxicam (2.5 mg/mL) in 10 mL glass vials; Meloxicam Sterile 50 ml vial (5 mg/mL) in glass vials; For IV or SC Use, Rx. Lot: 07152015@35 BUD: 10/13/2015, 09012015@22 BUD: 11/30/2015, 09012015@47 BUD: 11/30/2015, 07172015@65 BUD: 10/15/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Methionine/Inositol/Choline Chloride/B12 Sterile 100 mL Vial (25 mg/50 mg/50 mg/0.2 mg/mL) in amber glass vials; For IM Use Only, Rx. Lot: 04292015@5 BUD: 10/19/2015, 06012015@68 BUD: 10/19/2015, 06012015@69 BUD: 10/19/2015, 07272015@39 BUD: 1/23/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Methocarbamol 100 mL Vial (100 mg/mL) in clear glass vials; For IV or IM Injection, Rx. Lot: 06122015@2 BUD: 10/9/2015, 07212015@11 BUD: 11/17/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Metronidazole (VET) Sterile 100 mL vial (100 mg/mL) in glass vials; For IM Use Only, Rx. Lot: 05182015@77 BUD: 9/13/2015, 06292015@127 BUD: 9/13/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Miconazole Ointment 4 gm tube (1%) in metal tubes; For Topical Ophthalmic Use, Rx. Lot: 03302015@21 BUD: 9/16/2015, 05132015@47 BUD: 9/16/2015, 05192015@72 BUD: 9/16/2015, 06012015@50 BUD: 9/16/2015, 06042015@89 BUD: 12/1/2015, 06182015@55 BUD: 12/1/2015, 08102015@60 BUD: 12/1/2015, 09032015@43 BUD: 12/1/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Na Acet./KCl/CaCl/MgCl/Dextrose Sterile 100 mL Vial (100/0.7/0.3/0.2/50 mg/mL) in amber glass vials: For IV injection After Dilution, Rx. Lot: 03162015@30 BUD: 9/12/2015, 03312015@43 BUD: 9/27/2015, 04272015@29 BUD: 10/24/2015, 05062015@38 BUD: 11/2/2015, 06112015@25 BUD: 12/8/2015, 07082015@6 BUD: 1/4/2016, 07092015@41 BUD: 1/7/2016, 08112015@18 BUD: 2/7/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Naloxone (0.5 mg/mL) in 10 mL glass vial; For IM and IV Use, Rx. Lot: 04062015@43 BUD: 9/20/2015, 04222015@61 BUD: 9/30/2015, 05012015@20 BUD: 9/30/2015, 07082015@21 BUD: 1/3/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary N-Butyl Alcohol Sterile 100 mL vial (7%) in glass vials; For IM Use Only, Rx. Lot: 03172015@9 BUD: 9/13/2015, 03182015@14 BUD: 9/14/2015, 03262015@11 BUD: 9/22/2015, 04032015@23 BUD: 9/30/2015, 04282015@9 BUD: 10/25/2015, 06182015@61 BUD: 12/15/2015, 06232015@37 BUD: 12/20/2015, 07012015@13 BUD: 12/28/2015, 07132015@70 BUD: 1/9/2016, 08112015@38 BUD: 1/31/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Neomycin/Bacitracin/Polymyxin-B Ophthalmic 4 gm Tube (3.5 mg/400 IU/10000 U/gm) in metal tubes; For Topical Ophthalmic Use, Rx. Lot: 04232015@58 BUD: 9/16/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Pen-G/Dexameth./Chlorphenir/Gentamicin (200,000U/0.5/5/20 mg/mL) in 100 mL glass vials; For IM Use Only, Rx. Lot: 04232015@30 BUD: 10/20/2015, 07092015@37 BUD: 1/5/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Pen-G/Dexameth./Chlorpheniramine (200,000U/0.5 mg/5 mg/mL) in 100 mL glass vials; For IM Use Only, Rx. Lot: 06022015@47 BUD: 11/29/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Pentosan 100 mL Vial (250 mg/mL) in amber glass vials; Pentosan 50 mL Vial (250 mg/mL) in amber glass vials; Pentosan 6 mL in 10 mL Vial (250 mg/mL) in amber glass vials; For IM Use Only, Rx. Lot: 04292015@49 BUD: 10/26/2015, 06242015@49 BUD: 12/21/2015, 06242015@78 BUD: 12/21/2015, 07152015@81 BUD: 1/11/2016, 03182015@34 BUD: 9/14/2015, 05122015@77 BUD: 11/7/2015, 06232015@5 BUD: 12/19/2015, 04202015@4 BUD: 10/17/2015, 04272015@44 BUD: 10/24/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Pluronic 30% Gel Sterile (30%) in 20 mL Syringe; For Wound Care, Rx. Lot: 07202015@8 BUD: 1/16/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Praziquantel/Lidocaine Injection (VET) (56.8/5 mg/mL) in 50 mL glass vials; For IM Use Only, Rx. Lot: 07152015@55 BUD: 10/13/2015, 09022015@28 BUD: 12/1/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Progest./Estradiol-17B, Sesame Oil Sterile 100 mL Vial (50 mg/3.33 mg/mL) in glass vials; For IM Use Only, Rx. Lot: 06242015@46 BUD: 12/21/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Progesterone in Sesame Oil Sterile 100 mL Vial (150 mg/mL) in glass vials; Progesterone in Sesame Oil Sterile 100 mL Vial (100 mg/mL) in glass vials Lot: 04222015@6 BUD: 10/19/2015, 06042015@24 BUD: 12/1/2015, 06042015@29 BUD: 12/1/2015, 07142015@48 BUD: 1/10/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Pyrilamine Maleate Sterile 100 mL Vial (20 mg/mL) in amber glass vials; Pyrilamine Maleate Sterile 100 mL Vial (100 mg/mL) in glass vials; For IV Use, Rx. Lot: 04172015@12 BUD: 10/14/2015, 04272015@26 BUD: 10/24/2015, 05212015@6 BUD: 11/17/2015, 06022015@48 BUD: 11/29/2015, 0812205@29 BUD: 2/8/2016, 09012015@4 BUD: 2/28/2016, 09032015@75 BUD: 3/1/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Sesame Oil, Sterile 10 mL Vial (100% oil) in glass vials; For IM Use Only, Rx. Lot: : 04152015@35 BUD: 10/12/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Progesterone in Sesame Oil Sterile 100 mL Vial (150 mg/mL) in glass vials; Progesterone in Sesame Oil Sterile 100 mL Vial (100 mg/mL) in glass vials; For IM Use Only, Rx. Lot: 04222015@6 BUD: 10/19/2015, 06042015@24 BUD: 12/1/2015, 06042015@29 BUD: 12/1/2015, 07142015@48 BUD: 1/10/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Stanozolol 10 mL Vial (50 mg/mL) in glass vials; Stanozolol 30 mL Vial (50 mg/mL) in glass vials; For IM Injection Only, Rx. Lot: : 07072015@35 BUD: 1/3/2016, 06162015@51 BUD: 12/13/2015, 07072015@66 BUD: 1/3/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Tolazoline Sterile 100 mL Vial (10%(100 mg/mL)) in amber glass vials; For IV Use, Rx. Lot: : 05062015@23 BUD: 10/18/2015, 05072015@14 BUD: 10/18/2015, 05192015@45 BUD: 11/15/2015, 08102015@34 BUD: 2/3/2016, 09042015@30 BUD: 3/2/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Tranexamic Acid (100 mg/mL) in 100 mL glass vials; For IV Use, Rx. Lot: : 08072015@28 BUD: 11/5/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Triamcinolone Diacetate 100 mL Vial (2 mg/mL) in amber glass vials; For IM & Regional Injection, Rx. Lot: : 04152015@12 BUD: 10/12/2015, 06242015@62 BUD: 12/21/2015, 07062015@45 BUD: 1/2/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Triamcinolone Diacetate 5 mL in 10 mL (6 mg/mL) amber glass vials; For IM & Regional Use Only, Rx. Lot: : 07062015@52 BUD: 1/2/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Triamcinolone Diacetate PF 2 mL vial (6 mg/mL) in amber glass vials; For IM & Regional Injection, Rx. Lot: : 06182015@38 BUD: 12/15/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Tripelennamine HCL injection (20 mg/mL) in 100 mL amber glass vials; For IV or IM Use Only, Rx Lot: : 03262015@13 BUD: 9/22/2015, 04092015@18 BUD: 10/6/2015, 05182015@13 BUD: 11/14/2015, 05182015@74 BUD: 11/14/2015, 05222015@43 BUD: 11/14/2015, 06012015 BUD: 11/28/2015, 06012015@35 BUD: 11/28/2015, 06102015@72 BUD: 12/7/2015, 06102015@72 BUD: 12/7/2015, 07172015@41 BUD: 11/14/2015, 07282015@116 BUD: 1/17/2016, 08052015@15 BUD: 1/17/2016, 09012015@42 BUD: 2/28/2016, 09032015@74 BUD: 2/28/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Tryptophan (L) 100 mL Vial (100 mg/mL) in amber glass vials; For IM Use Only, Rx. Lot: : 05112015@11 BUD: 11/7/2015, 05142015@20 BUD: 11/10/2015, 06022015@35 BUD: 11/29/2015, 07152015@91 BUD: 1/11/2016, 07282015@99 BUD: 1/24/2016, 08312015@85 BUD: 1/25/2016 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Voriconazole Ointment (1% (10 mg/mL)) in 4 gm metal tubes; For Topical Ophthalmic Use, Rx. Lot: : 08312015@43 BUD: 9/14/2015, 09092015@54 BUD: 9/23/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Voriconazole Ophthalmic (1% (10 mg/mL)) in 15 mL dropper bottles; For Topical Ophthalmic Use, Rx. Lot: : 08312015@43 BUD: 9/14/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Xylazine HCl Preservative Free Sterile (333 mg/mL) in 20 mL glass vials; Xylazine Preservative Free (300 mg/mL) in 100 mL glass vials; For IM or IV Use. Lot: : 04032015@21 BUD: 9/30/2015, 07152015@88 BUD: 1/11/2016, 05212015@5 BUD: 11/17/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Yohimbine-Compound Sterile (5 mg/mL (0.5%)) in 100 mL glass vials; Yohimbine HCl-Compound Sterile (5 mg/mL (0.5%)) in 100 mL glass vials; For IM Use Only, Rx. Lot: : 05072015@34 BUD: 11/3/2015, 06152015@33 BUD: 11/16/2015, 06252015@55 BUD: 11/16/2015, 07092015@18 BUD: 11/3/2015, 07102015@12 BUD: 1/3/2016, 08042015@91 BUD: 1/31/2016, 09042015@4 BUD: 2/6/2016, 04202015@44 BUD: 9/20/2015, 04302015@43 BUD: 10/19/2015 Class II Lack of sterility assurance. US Compounding Inc
Veterinary Desmopressin 0.01% Ophtalmic Solution Sterile, For Dogs. Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 LoT # 08042015@14, BUD 09/14/2015 Class II Lack of assurance of sterility Bedford Pharmacy
Food Butternut Squash Triangoli, Net Wt. 8.8 oz (250g) SKU 94348, Use or Freeze by codes 04 16 15 through 01 15 16 Class I Trader Joe's is recalling Trader Giotto's Butternut Squash Triangoli because it may contain undeclared tree nuts. Trader Joes Company
Food Hannaford CHEESE crispy thin crust pizza KEEP FROZEN NET WT 5.2 OZ (147Gg) (U) INGREDIENTS: CRUST***SAUCE***MOZZARELLA CHEESE BLEND***CONTAINS: WHEAT, SOY, MILK. DISTRIBUTED BY: HANNAFORD BROS. CO., SCARBOROUGH, ME 04074 UPC 0 41268 19400 1 USE BY 9/30/16 & 10/26/2016 Class III The product contains the Kosher symbol on its retail packaging. This symbol is a trademark of the Orthodox Union representing Kosher status. None of our products are not Kosher. Frozen Specialties Inc
Food FOOD LION CHEESE crispy thin crust pizza KEEP FROZEN NET WT 5.2 OZ (147Gg) (U) INGREDIENTS: CRUST***SAUCE***MOZZARELLA CHEESE BLEND***CONTAINS: WHEAT, SOY, MILK. DISTRIBUTED BY: FOOD LION, LLC, SALISBURY, NC 28147 UPC 0 35826 08815 4 USE BY: 8/15/16, 8/18/16, 8/26/16, 8/28/16, 9/1/16, 9/11/16, 9/22/16, 10/1/16, 10/13/16, 10/20/16 & 10/23/16. Class III The product contains the Kosher symbol on its retail packaging. This symbol is a trademark of the Orthodox Union representing Kosher status. None of our products are not Kosher. Frozen Specialties Inc
Food FOOD LION CHEESE microwaveable crispy thin crust pizza KEEP FROZEN NET WT 5.2 OZ (147Gg) (U) INGREDIENTS: CRUST***SAUCE***MOZZARELLA CHEESE BLEND***CONTAINS: WHEAT, SOY, MILK. DISTRIBUTED BY: FOOD LION, LLC, SALISBURY, NC 28147 UPC 0 35826 08821 5 USE BY: 7/22/16, 7/28/16, 8/6/16, 8/10/16, 8/15/16, 8/19/16, 8/26/16, 8/29/16, 9/25/16, 10/1/16 & 10/23/16. Class III The product contains the Kosher symbol on its retail packaging. This symbol is a trademark of the Orthodox Union representing Kosher status. None of our products are not Kosher. Frozen Specialties Inc
Food Cashew Cardamom - Sprouted Cashew Almond Spread. Product is packaged in glass jars, sold under brand name JEM Raw Organics. Net wt. 1 oz., UPC 6 09728 97861 7; Net wt. 6 oz., UPC 6 09728 97860 0; Net wt. 16 oz., UPC 6 09728 97854 9; The product is labeled in parts: "***ORGANIC INGREDIENTS Almonds, Cashews, Coconut Sugar, Lucuma, Vanilla, Cardamon***". Lot/Batch # 1685-2022. Best by dates range from 062116 through 103016 (means 6/21/2016 through 10/30/2016). The lot/batch numbers are a sequential number, starting with the beginning of operations. The number is independent of the product being manufactured. The digits themselves have no specific meaning. Class I Cashew Cardamom - Sprouted Cashew Almond Spread is recalled because it has the potential to be contaminated with Salmonella Jem Raw Chocolate, LLC
Food Cinnamon Red Maca - Sprouted Almond Spread. Product is packaged in glass jars, sold under brand name JEM Raw Organics. Net wt. 1 oz., UPC 6 09728 97862 4; Net wt. 6 oz., UPC 6 09728 97848 8; Net wt. 16 oz., UPC 6 09728 97850 1; The product is labeled in parts: "***ORGANIC INGREDIENTS Almonds, Coconut Sugar, Maca, Ground Cinnamon, Vanilla***". Lot/Batch # 1685-2022. Best by dates range from 062116 through 103016 (means 6/21/2016 through 10/30/2016). The lot/batch numbers are a sequential number, starting with the beginning of operations. The number is independent of the product being manufactured. The digits themselves have no specific meaning. Class I Cinnamon Red Maca - Sprouted Almond Spread is recalled because it has the potential to be contaminated with Salmonella Jem Raw Chocolate, LLC
Food Hazelnut Raw Cacao - Sprouted Hazelnut Spread. Product is packaged in glass jars, sold under brand name JEM Raw Organics. Net wt. 1 oz., UPC 6 09728 97865 5; Net wt. 6 oz., UPC 6 09728 97857 0; Net wt. 16 oz., UPC 6 09728 97851 8; The product is labeled in parts: "***ORGANIC INGREDIENTS Hazelnuts, Coconut Sugar, Cacao Nibs, Vanilla***". Lot/Batch # 1685-2022. Best by dates range from 062116 through 103016 (means 6/21/2016 through 10/30/2016). The lot/batch numbers are a sequential number, starting with the beginning of operations. The number is independent of the product being manufactured. The digits themselves have no specific meaning. Class I Hazelnut Raw Cacao - Sprouted Hazelnut Spread is recalled because it has the potential to be contaminated with Salmonella Jem Raw Chocolate, LLC
Food Superberry Maqui Camu - Sprouted Almond Spread. Product is packaged in glass jars, sold under brand name JEM Raw Organics. Net wt. 1 oz., UPC 6 09728 97864 8; Net wt. 6 oz., UPC 6 09728 97858 7; Net wt. 16 oz., UPC 6 09728 97852 5; The product is labeled in parts: "***ORGANIC INGREDIENTS Almonds, Coconut Sugar, Maqui Berry, Lucuma, Vanilla, Camu***". Lot/Batch # 1685-2022. Best by dates range from 062116 through 103016 (means 6/21/2016 through 10/30/2016). The lot/batch numbers are a sequential number, starting with the beginning of operations. The number is independent of the product being manufactured. The digits themselves have no specific meaning. Class I Superberry Maqui Camu - Sprouted Almond Spread is recalled because it has the potential to be contaminated with Salmonella Jem Raw Chocolate, LLC
Food Coconut Cardamom - Sprouted Almond Spread. Product is packaged in glass jars, sold under brand name JEM Raw Organics. Net wt. 1 oz., UPC 6 09728 97863 1 Net wt. 6 oz., UPC 6 09728 97859 4 Net wt. 16 oz., UPC 6 09728 97853 3 The product is labeled in parts: "***ORGANIC INGREDIENTS Almonds, Coconut, Coconut Palm Sugar, Lucuma, Vanilla, Cardamom, Spices***". ***THIS ITEM BEING PHASED OUT AND DISCONTINUED. THE FIRM RECALLED IT AFTER THE PRESS RELEASE ISSUED ON 12/2/15 SO THIS ITEM IS NOT LISTED IN THE PRESS RELEASE. Lot/Batch # 1685-2022. Best by dates range from 062116 through 103016 (means 6/21/2016 through 10/30/2016). The lot/batch numbers are a sequential number, starting with the beginning of operations. The number is independent of the product being manufactured. The digits themselves have no specific meaning. Class I Coconut Cardamom- Sprouted Almond Spread is recalled because it has the potential to be contaminated with Salmonella Jem Raw Chocolate, LLC
Devices Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient. lot/batch numbers 13-23, 13-24, 13-29, 13-30, 13-31, 13-32, 97750, 97774, 97777, 97870, 97871, 97873, 97874, 97880, 97988, 98030, 98031, 98033, 98034, 98043, 98048, 98058, 98059, 98099, 98103, 98330, 98338, 98380, 98491, 98520, 98546, 98556, 98570, 98571, 98578, 98595, 98635, 98683, 98694, 98721, 98722, 98730, 98733, 98738, 98777, 98779, 98782, 98840,  ...
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Class II The Nebulizer mask malfunctions in that there is reduced or no aerosol output. The malfunction occurs from the reduction in the diameter of a component part inside the nebulizer. ConvaTec, Inc
Devices Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint. All codes Class II Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem implant packaging that are used for Columbus Revision/Enduro Knee Implants because it is labeled as Cementless. US product is indicated in the US for use with Bone Cement only. Aesculap, Inc.
Biologics Red Blood Cells, Leukocytes Reduced W141614572540 Class II Misbranded red blood cell was distributed. Puget Sound Blood Center and Program
Biologics Apheresis Platelets, Leukocytes Reduced W071215046255 (triple collection); W071215046269 (triple collection) Class III Platelet products, for which a quality control procedure was not performed, were distributed. Medic Inc
Drugs Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7474-89 Lot # 3A404012V, Exp. 4/2016 Class II Failed Dissolution Specifications: low test results at the 18 month time-point Teva North America
Biologics Cornea 151963100; 151963200 Class II 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. Rocky Mountain Lions Eye Bank
Biologics Red Blood Cells, Leukocytes Reduced W120615441353; W120615410654; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed Michigan Blood
Drugs Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023 Lot # 07142015#7192@1, Exp 09/12/2015; 09112015#7192@1, Exp 11/10/2015; 10082015#7192@9, Exp 12/07/2015; 11302015#71920@1, Exp 1/30/2016 Class II Lack of assurance of sterility TexasStar Pharmacy
Devices NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box. 3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 5430008-5. 3.0T GEM Flex Coil16-L Array, NC040200, GEHC part number 5430008-2. 3.0T GEM Flex Coil 16-M Array, NC033000, GEHC part number 5430008-3. 3.0T GEM Flex Coil 16-S Array, NC034200, GEHC part number5430008-4. The 3.0T GEM Flex Coil (interface box and arrays) is used in conjunction with a 3.0T GE Magnetic Resonance Scanner Mfg Lot or Serial # System ID 0000034-4-0130 608263MR5W 0000040-4-0135 608263MR5W 000032E-4-0151 608263MR5W 033-4-0151 608263MR5W 0000040-4-0202 602863MR 0000033-4-0204 602863MR 034-4-0265 602863MR 040-4-0076 602863MR 0000034-4-0250 703478MR2DV 0000040-4-0270 703478MR2DV 033-4-022 703478MR2DV 0000033-4-0272 703478MR2DV 034-4-0255 506648MR4 040-4-0275 506648MR4 040-4-0020 506648MR4 033-4-0277 506648MR4 034-4-0071 608265MR750W 0000040-4-0381 608265MR750W 0000033-4-0384 608265MR750W 034-4-0345 608265MR750W 0000034-4-0093  ...
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Class II Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns. NeoCoil, LLC
Biologics Red Blood Cells, Leukocytes Reduced W200715121361 Class III Mislabelled RBC was distributed. American National Red Cross, The
Biologics Red Blood Cells, Leukocytes Reduced W203215307918 Class III Mislabelled RBC was distributed. American National Red Cross (The)
Biologics Red Blood Cells, Leukocytes Reduced W203815230065 Class III Mislabelled RBC was distributed. American Red Cross Blood Svs. Indiana-Ohio Region
Biologics Red Blood Cells W050911030167 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Fresh Frozen Plasma W050911030167 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Red Blood Cells, Leukocytes Reduced W044215378460 Class III Red blood cells, not prepared in accordance with specifications, were distributed. San Diego Blood Bank
Biologics Red Blood Cells, Leukocytes Reduced W067115054445; W067115028631 Class II Blood products, collected from a donor whose suitability to donate was inadequately determined, were distributed. The Blood Center
Biologics Blood and Blood Products for Reprocessing W067115028631 Class III Blood products, collected from a donor whose suitability to donate was inadequately determined, were distributed. The Blood Center
Biologics Red Blood Cells Deglycerolized, Leukocytes Reduced W036310290347 Class III Blood component, not prepared in accordance with specifications, was distributed. The Blood Connection, Inc.
Devices BrightView are gamma cameras; Designed for single or dual detector nuclear imaging. Model # 882480; Serial #'s: 4000002, 4000002.75, 4000003, 4000004, 4000006, 4000007, 4000008, 4000009, 4000010, 4000011, 4000013, 4000030, 4000031, 4000032, 4000033, 4000034, 4000035, 4000036, 4000037, 4000038, 4000039, 4000040, 4000041, 4000043, 4000044, 4000045, 4000046, 4000047, 4000048, 4000049, 4000050, 4000051, 4000052, 4000053, 4000054, 4000055, 4000056, 4000057, 4000058, 4000059, 4000060, 4000061, 4000062, 4000064, 4000065,  ...
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Class II The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Issue 2: During a scan, the gantry motion may halt prematurely. This causes the scan sequence to pause. Incidences of scan sequence pause have been reported to occur more often after installation of the following software: " Version 1.2.4 for BrightView. " Version 2.5.4 for BrightView X, BrightView XCT and BrightView XCT Upgrade Issue 3: The operator will receive a warning message indicating that the scan may not complete when defined with the following scan parameters: " Detector Relative Angle: 90 " Head first supine OR feet first prone This message further instructs the operator to re-mark the points used to define the orbit. Issue 4: The Resolved Defects section of the User Release Document 1.2.4/2.5.4 for BrightView, BrightView X and BrightView XCT (45980022532 Rev A) listed two Pre-Programmed Motions (PPMs) whose motion sequences were changed by the release of software version 1.2.4/ 2.5.4. The software has been updated so that the patient table is extracted before detectors are in motion. In addition to the two PPMs in the User Release Document, the following 31 PPMs have also changed motion sequence: " DH Hands Left " DH Hands Right " DH Sitting " DH Standing " Install Head Holder* " Remove Head Holder* " Anterior Oblique 30 " Posterior Oblique 30 " Anterior Oblique 60 " Posterior Oblique 60 " Anterior Oblique 45 " Posterior Oblique 45 " Seated Plantar " SH Posterior Det 1 " SH Posterior Det 2 " Planar " Pallet Change " Outerroom Det 1 Left " Outerroom Det 1 Right " Outerroom Det 2 Left " Outerroom Det 2 Right " Bed Imaging " Rel 90 Test Spin** " Rel 180 Test Spin** " PinHole*** " PinHole Anterior* " PinHole Posterior* " Lung -Pallet In " Lung -Rotate CW 45° " Lung -Rotate CCW 45° " Lung -Pallet Out *Applicable only to BrightView X and BrightView XCT ** Applicable only to BrightView XCT ***Applicable only to BrightView Philips Medical Systems (Cleveland) Inc
Devices BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging. Model #: 882478; Serial #'s: 11000003, 11000008, 11000030, 11000004, 11000005, 11000006, 11000007, 11000009, 11000010, 11000011, 11000012, 11000013, 11000014, 11000016, 11000017, 11000018, 11000019, 11000020, 11000022, 11000023, 11000024, 11000025, 11000026, 11000027, 11000028, 11000029, 11000031, 11000032, 11000033, 11000034, 11000035, 11000036, 11000037, 11000038, 11000039, 11000040, 11000041, 11000042, 11000043, 11000044, 11000045, 11000046, 11000047, 11000048, 11000049,  ...
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Class II The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Issue 2: During a scan, the gantry motion may halt prematurely. This causes the scan sequence to pause. Incidences of scan sequence pause have been reported to occur more often after installation of the following software: " Version 1.2.4 for BrightView. " Version 2.5.4 for BrightView X, BrightView XCT and BrightView XCT Upgrade Issue 3: The operator will receive a warning message indicating that the scan may not complete when defined with the following scan parameters: " Detector Relative Angle: 90 " Head first supine OR feet first prone This message further instructs the operator to re-mark the points used to define the orbit. Issue 4: The Resolved Defects section of the User Release Document 1.2.4/2.5.4 for BrightView, BrightView X and BrightView XCT (45980022532 Rev A) listed two Pre-Programmed Motions (PPMs) whose motion sequences were changed by the release of software version 1.2.4/ 2.5.4. The software has been updated so that the patient table is extracted before detectors are in motion. In addition to the two PPMs in the User Release Document, the following 31 PPMs have also changed motion sequence: " DH Hands Left " DH Hands Right " DH Sitting " DH Standing " Install Head Holder* " Remove Head Holder* " Anterior Oblique 30 " Posterior Oblique 30 " Anterior Oblique 60 " Posterior Oblique 60 " Anterior Oblique 45 " Posterior Oblique 45 " Seated Plantar " SH Posterior Det 1 " SH Posterior Det 2 " Planar " Pallet Change " Outerroom Det 1 Left " Outerroom Det 1 Right " Outerroom Det 2 Left " Outerroom Det 2 Right " Bed Imaging " Rel 90 Test Spin** " Rel 180 Test Spin** " PinHole*** " PinHole Anterior* " PinHole Posterior* " Lung -Pallet In " Lung -Rotate CW 45° " Lung -Rotate CCW 45° " Lung -Pallet Out *Applicable only to BrightView X and BrightView XCT ** Applicable only to BrightView XCT ***Applicable only to BrightView Philips Medical Systems (Cleveland) Inc
Devices BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography. Model #: 882482; Serial #'s: 6000016, 6000111, 6000114, 6000122, 6000002, 6000003, 6000004, 6000005, 6000006, 6000010, 6000011, 6000012, 6000013, 6000015, 6000017, 6000018, 6000019, 6000020, 6000022, 6000023, 6000024, 6000025, 6000026, 6000027, 6000028, 6000029, 6000030, 6000031, 6000032, 6000033, 6000035, 6000036, 6000037, 6000038, 6000040, 6000041, 6000042, 6000043, 6000044, 6000045, 6000047, 6000048, 6000049, 6000050, 6000051,  ...
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Class II The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Issue 2: During a scan, the gantry motion may halt prematurely. This causes the scan sequence to pause. Incidences of scan sequence pause have been reported to occur more often after installation of the following software: " Version 1.2.4 for BrightView. " Version 2.5.4 for BrightView X, BrightView XCT and BrightView XCT Upgrade Issue 3: The operator will receive a warning message indicating that the scan may not complete when defined with the following scan parameters: " Detector Relative Angle: 90 " Head first supine OR feet first prone This message further instructs the operator to re-mark the points used to define the orbit. Issue 4: The Resolved Defects section of the User Release Document 1.2.4/2.5.4 for BrightView, BrightView X and BrightView XCT (45980022532 Rev A) listed two Pre-Programmed Motions (PPMs) whose motion sequences were changed by the release of software version 1.2.4/ 2.5.4. The software has been updated so that the patient table is extracted before detectors are in motion. In addition to the two PPMs in the User Release Document, the following 31 PPMs have also changed motion sequence: " DH Hands Left " DH Hands Right " DH Sitting " DH Standing " Install Head Holder* " Remove Head Holder* " Anterior Oblique 30 " Posterior Oblique 30 " Anterior Oblique 60 " Posterior Oblique 60 " Anterior Oblique 45 " Posterior Oblique 45 " Seated Plantar " SH Posterior Det 1 " SH Posterior Det 2 " Planar " Pallet Change " Outerroom Det 1 Left " Outerroom Det 1 Right " Outerroom Det 2 Left " Outerroom Det 2 Right " Bed Imaging " Rel 90 Test Spin** " Rel 180 Test Spin** " PinHole*** " PinHole Anterior* " PinHole Posterior* " Lung -Pallet In " Lung -Rotate CW 45° " Lung -Rotate CCW 45° " Lung -Pallet Out *Applicable only to BrightView X and BrightView XCT ** Applicable only to BrightView XCT ***Applicable only to BrightView Philips Medical Systems (Cleveland) Inc
Biologics Cryoprecipitated AHF W0410151545545 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. United Blood Services
Biologics Blood and Blood Products for Reprocessing W041015147431B Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. United Blood Services
Biologics Apheresis Red Blood Cells, Leukocytes Reduced W200315426930(double collection) Class III Mislabelled RBC was distributed. The American National Red Cross - Southern Region
Devices Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot #15246MA Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B2-microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B2-microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease. Lot #: 15037MA - foreign 15175MA - foreign 15204MA- foreign 15246MA (Distributed in US) 15267MA - foreign Class II Siemens Healthcare Diagnostics has confirmed an increase in the rate of Abnormal Assay errors and calibration failures with the Dimension Vista B2MIC Flex reagent cartridge: Dimension Vista System Flex reagent cartridge and urine stabilizer B2MIC. In the unlikely event that a patient result is generated, a suppressed result would be in conflict with the patients clinical status and other markers of renal injury. Siemens Healthcare Diagnostics, Inc.
Devices Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a hookwire. The hookwire features a burnish mark that allows the operator to ensure that the hookwire is within the needle tip during needle manipulation. The Kopans Breast Lesion Localization Needle is intended for preoperative marking of nonpalpable breast lesions. Catalog # DKBL-20-7.0-A Lot # 6215428 date of manufacture 09/17/2015 Class II Product potentially exposed to body fluids during processing. Potential adverse events that may occur as a result of the foreign matter include blood borne pathogen transmission. However, the risk of transmission of blood borne pathogens is thought to be minimal to non-existent since these devices were sterilized after the potential exposure to body fluids. Cook Inc.
Biologics Source Plasma JV0185459; JV0186687; JV0187439; JV0188648; JV0189565; JV0190643; JV0191245 Class II Plasma products, collected from a donor who received a tattoo within 12 months of donating, were distributed. BPL Plasma, Inc.
Devices Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm), Sterile; Catalog Number: 461438. Intended for pediatric feeding. Lot Code: 521807764X Class II 8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were packaged in an 8FR 20 Polyurethane packs Covidien LLC
Devices Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 8 Fr/Ch (2.7 mm) x 20" (51 cm); Catalog Number: 461701. Intended for pediatric feeding. Lot Code: 521808064X Class II 8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were packaged in an 8FR 20 Polyurethane packs Covidien LLC
Food Heartland Flax 14 Mesh Brown RCM Flax Certified Organic, Net WT 50 lbs. Product packaged in 50 lb Food Grade Plastic bags. Lot 2T330-040515-101 Class I Heartland Products Inc., has initiated a recall due to potential contamination with Salmonella involving Milled Flax. Heartland Products, Inc.
Food Freeze Dried Mango Powder, Item no. 30042. Nutrifruit brand. Each plastic jar has a net wt. 5 oz. The UPC is 0 79947 00110 4. best by dates: 3/12/2016 8/2/2016 9/11/2016 4/13/2017 Lot code (internal): D1888255 E0140033 E0307070 E1486286 Class II Label error in the supplement facts panel indicating 625.7 grams of carbohydrates in each serving. The correct amount is 6 grams carbohydrate per serving. Scenic Fruit Company
Food Freeze Dried Black Raspberry Powder, Item no. 30007 or 30041. Nutrifruit brand. Each plastic jar has a net wt. 5 oz. The UPC is 0 79947 00019 0. Best by dates: 2/5/2016 3/12/2016 5/17/2016 8/23/2016 9/11/2016 10/23/2016 11/21/2016 1/21/2017 2/7/2017 2/27/2017 3/23/2017 4/13/2017 4/19/2017 4/30/2017 LOT NUMBERS (INTERNAL): Lot No. D1417217 D1902255 D2251321 E0237054 E0308070 E0595113 E0746141 E1148202 E1258219 E1347239 E1428266 E1482286 E1507292 E1542303 Class II Label error in the supplement facts panel indicating 0 gram of sugar in each serving. The correct amount is 2 grams of sugar per serving. Scenic Fruit Company
Food Classic Garden Salad, 12 oz. bag: Aldi, Kroger 24 oz. bag. - Kroger All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Aldi Production code 3210: Kroger production codes: 3007 (12 oz.) and 3009. (24 oz.). Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Spinach, 8 oz. bag, - Aldi; Teen Spinach - 10 oz. bag - Walmart. All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Aldi - production code 3211; Walmart - production code_ 34123. Walmart - production code- 3123. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Spring Salad Mix, 5 oz. bag, - Aldi; Walmart; 5 oz, and 10 oz. clamshell - Kroger; Dole - 3 lb. bag, 11 oz and 5 oz.. clamshell All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Aldi - production code 3213; Walmart - production code 3145; Kroger - production code 3017 (10 oz. ) 3023 (5 oz.); Dole - production cide 682 (3 lb), 665 and 336 (11 oz. clamshell), 946 (5 oz. clamshell) Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Italian Blend, 9 oz. bag, - Aldi; Kroger; Dole. All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Aldi - production code 3215; Kroger - production code 3010; Dole - production code 686. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Caesar Kit, 10 oz. bag, - Aldi; Dole 14.53 oz bag, 22.30 oz. - Walmart; Value Size All Natural Caesar Kit , 15 oz. bag - Dole All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Aldi - production code 3214; Walmart - Production code 3124, Family size 3114; Dole - production code 678 (10 oz), 158 (15 oz.). Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Leafy Romaine Salad, 10 oz. 10 oz. bag, - Walmart; Leafy Romaine, 10 oz. bag - Kroger Romaine Blend - 10 oz. bag - Kroger All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Walmart - production code 3141; Kroger- production code: 3005, 3011 (leafy romaine) Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food American Salad, 12 oz. bag, - Walmart; American Blend 12 oz. bag - Kroger; American 12 oz. bag - Dole All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Walmart - production code 3143; Kroger - production code 3003; Dole - production code 687 Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Hearts of Romaine Salad, 10 oz. bag, - Walmart; Hearts of Romaine 10 oz. bag - Kroger; Hearts of Romaine 9 oz. bag - Dole Classic Romaine, 9 oz. bag - Dole Value Size Classic Romaine, 15 oz. bag - Dole All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Walmart - production code 3140; Dole - production code 696 and 2683, Values size - 534. Kroger - production code 3002; Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Baby Spinach , 6 oz. bag, - Walmart; 6 oz and 10 oz. clamshell - Kroger; 11 oz and 5 oz. clamshell - Dole All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Walmart - production code 3131 (10 oz) and 3025 (6 oz.) Kroger - production code 3015; Dole - production code 337 (11 oz), 949 (5 oz.). Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Caesar Bacon Salad Kit, 14.54 oz. bag - Walmart; All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Walmart - production code 3111. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Chop Romaine Display, 2 lb. bag - Sam's Club; Chopped Romaine - 16 oz. bag and 2 lb bag- Dole All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Sam's Club production code - 501; Dole production code- 963 (16 oz) and 675, 78 (2 lb) Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Colorful Coleslaw Display, 2 lb. bag - Sam's Club; Colorful Coleslaw - 14 oz. bag- Dole All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Sam's Club production code - 503; Dole production code- 2662. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Classic Iceberg Display, 2 lb. bag - Sam's Club; Value Size Classic Iceberg Salad, 24 oz. bag and 12 oz. bag- Dole All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Sam's Club production code - 504; Dole production code- 2009 (24 oz) and 2697 (12 oz.). Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food All Natural Chopped Sesame Asian Family Kit, 27.2 oz. bag - Sam's Club; 13.6 oz. Dole Brand All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Sam's Club production code - 618; Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food All Natural Chopped Sunflower Family Crunch, 27.2 oz. bag - Sam's Club; 13.6 oz. Dole brand All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Sam's Club production code - 619; Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Organic Baby Spinach - 11 oz. and 5 oz. clamshell - Loblaw 5 oz and 16 oz, Clamshell - Kroger All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Loblaw production code - 3220 (11 oz) and 3224 (5 oz); Kroger production code - 3031 (5 oz) nd 3032 (16 oz). Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Organic Field Greens - 5 oz. and 11 oz. clamshell - Loblaw All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Loblaw production code - 3223 (5 oz), 3221 (11 oz). Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Southwest Salad, 13 oz. bag, Dole brand. All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Dole production code - 2976. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Organic Baby Arugula - 5 oz. clamshell - Loblaw All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Loblaw production code - 3225. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Organic Baby Romaine - 5 oz. clamshell - Loblaw All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Loblaw production code - 3226. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Organic Baby Kale - 5 oz. clamshell - Loblaw All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Loblaw production code - 3227. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Shredded Lettuce , 11 oz. bag - Kroger Value Size Shredded Lettuce - 16 oz. bag - Dole; 1/4'' Shredded Lettuce-Dole brand Chopped lettuce 5 lb bag - Dole. All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Kroger production code - 3029. Dole production code - 157 (186 oz) 75 (5 lb. bag) and 72 (1/4') Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Greener Supreme , 12 oz. bag - Kroger; Greener Selection, 12 oz. bag - Dole Value Size Greener Selection , 18 oz. bag - Dole All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Kroger production code - 3004. Dole production code - 695 (12 oz. and 159 (18 oz.). Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Coleslaw, 12 oz. bag - Kroger; All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Kroger production code - 3000. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Field Greens, 8 oz. bag - Kroger; All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Kroger production code - 3008. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Veggie Blend, 12 oz. bag - Kroger; Very Veggie, 12 oz. bag - Dole All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Kroger production code - 3013. Dole production code - 694 Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food 50/50 mix, 5.5 oz. bag - Kroger; 50/50 blend, 10 oz. bag - Dole All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Kroger production code - 3024. Dole production code - 938 Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food House Ranch, 10.6 oz. bag - Kroger; All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Kroger production code - 3021 Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food All Natural Chopped BBQ Ranch Kit; 14.4 oz. and Chopped BBQ Ranch 14.4oz. bag - Dole brand. All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Dole production code - 611 (14.4 oz all natural) and 991 (14.4 oz) Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food All Natural Chopped Bacon & Bleu Kit; 12.9 oz. bag - Dole brand. All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Dole production code - 612 Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food All Natural Chopped Chipotle & Cheddar Kit; 12.9 oz. bag and Chopped Chipotle & Cheddar kit, 12,9 oz. - Dole brand. All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Dole production code - 613 (all natural) and 993 Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Mediterranean, 8 oz. bag. Dole brand. All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Dole production code - 645 Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Baby Arugula with Spinach Clamshell, 5 oz. clamshell, Dole brand. . All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Dole production code - 941. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Baby Romaine, 5 oz. clamshell, Dole brand. . All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Dole production code - 942. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Baby Spinach with Tender Reds, 5 oz. clamshell, Dole brand. . All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Dole production code - 943. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Sweet Baby lettuces, 5 oz. clamshell, Dole brand. . All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Dole production code - 948. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Arugula, 5 oz. clamshell, Dole brand. . All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Dole production code - 950. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Light Caesar, 10 oz. bag, Dole brand. . All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Dole production code - 699. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Ultimate Caesar, 11.3 oz. bag, Dole brand. . All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Dole production code - 953. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Asian Island Crunch, 13 oz. bag, Dole brand. All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Dole production code - 930. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Southwest Salad, 13 oz. bag, Dole brand. All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Dole production code - 2976 Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Endless Summer Kit Bag, 8.8 oz. bag, Dole brand. All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Dole production code - 2701. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Kale Caesar Kit Bag, 9.2 oz. bag, Dole brand. All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Dole production code - 703. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Sweet Kale Kit Bag, 9.5 oz. bag, Dole brand. All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Dole production code - 704. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Chopped Italienne Kit, 12.6 oz. bag, Dole brand. All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Dole production code - 992. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Chopped Sesame Ginger Kit, 13.6 oz. bag, Dole brand. All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. All packaged salads with manufacturing code beginning with the letter A. Dole production code - 996. Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Classic Iceberg Blend, 5 lb. bag, Dole brand. All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. Dole production code: 76 Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Classic Iceberg Blend w/Red Cabbage and Carrots Separate, 5 lb. bag, Dole brand. All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. Dole production code: 77 Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Food Cole Slaw with Carrots Separate, 5 lb. bag, Dole brand. All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. Dole production code: 24 Class I Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility. Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package. Dole Fresh Vegetables Inc
Devices Karma Flexx Wheelchair Manual Wheelchair. Item # 935-0245H6 Flexx (KM852216) Serial # TM14-A03982-TM14-A03991 Item # 935-0246H6 Flexx (KM852218) Serial # TM14-A03992-TM14-A04012 Item # 935-0247H6 Flexx (KM852220) Serial # TM14-A4013-TM14-A04017 Class II Karman Healthcare, Inc. is recalling Karma Flexx Wheelchair because incorrect size screws and corresponding hardware were installed on the front caster fork brackets. Karman Healthcare Inc
Devices (Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography. Stryker Model: 0900-300-000; With lot numbers: 61405002, 61406007, 61408002, and 61509002. Devices distributed between 5-1-2013 and 5-31-2014 are labeled with Inrads name and product number. Devices distributed between 6-20-2014 and 12-3-15 are labeled with Strykers name and product number. Class II During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility. Stryker Instruments Div. of Stryker Corporation
Devices (Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography. Stryker Model: 0900-400-000; With lot numbers: 61406002, 61505003. Devices distributed between 5-1-2013 and 5-31-2014 are labeled with Inrads name and product number. Devices distributed between 6-20-2014 and 12-3-15 are labeled with Strykers name and product number. Class II During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility. Stryker Instruments Div. of Stryker Corporation
Devices 50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography. 50000 Lot numbers: 61305001, 61310001, 61312001, 61404006 Devices distributed between 5-1-2013 and 5-31-2014 are labeled with Inrads name and product number. Devices distributed between 6-20-2014 and 12-3-15 are labeled with Strykers name and product number. Class II During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility. Stryker Instruments Div. of Stryker Corporation
Devices 50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography. 50001 Lot numbers: 61303001, 61309001, 61310001, 61404006 Devices distributed between 5-1-2013 and 5-31-2014 are labeled with Inrads name and product number. Devices distributed between 6-20-2014 and 12-3-15 are labeled with Strykers name and product number. Class II During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility. Stryker Instruments Div. of Stryker Corporation
Food Apple Caramel Almond Tea, Bag Size - 2lbs Minimum, Bulk Packaging, Item No. FB-004 No codes, Distributed from 01/01/2014 To 01/25/2016. Class I International Tea Importers is recalling Apple, Caramel & Almond Tea because it contains undeclared milk. International Tea Importers
Food Braga Organic Farms Organic Pistachio Kernels, Raw; Certified Organic, USDA Organic. Packed in 8 oz. 1 lb. 2. lb and 5 lb clear or green standup bags. Ingredients: Organic Pistachios Braga Organic Farms, Madera, CA. Raw Pistachio Kernels: 8 oz - UPC: 896547002047, Best by or purchase date:JUN 29 2016, JUL 04 2016, JUL 18 2016, JUL 25 2016, JUL 26 2016: 1 lb - UPC: 810126020215, Purchased 12/28/15 to 1/27/16; 2 lbs - UPC: 896547002306; Best by or purchase date:JUN 28 2016, JUL 13 2016, JUL 27  ...
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Class I IEH sample had a positive result for Salmonella in Braga Organic Pistachios Braga Organic Farms, Inc.
Food Braga Organic Farms Organic Trail Mix, Raw; Certified Organic, USDA Organic. GMO Free, Peanut Free, Gluten Free Packed in 8 oz. 1 lb. 2. lb and 5 lb and 25 lb. clear or green standup bags. Ingredients: Organic Pistachios, organic almonds, Organic walnuts, Organic Jumbo Flame Raisins, Organic Cranberries, Organic Evaporated Cane Juice, Organic Sunflower oil. Braga Organic Farms, Madera, CA. Trail Mix: 8 oz, UPC: 896S47002139: Best by JUN 29 2016, JUL 7 2016, JUL 11 2016, JUL 26 2016; 1 lb, UPC: 81012602045: Purchased 12/28 to 1/29 21bs, UPC: 896S47002320; Purchased 12/28 to 1/29, JUL 01 2016 5 lbs, UPC: 896S47002603; Purchased 12/28 to 1/29 25 lbs., UPC: 896S47002492 Purchased 12/28 to 1/29. Lot codes  ...
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Class I IEH sample had a positive result for Salmonella in Braga Organic Pistachios Braga Organic Farms, Inc.
Food Braga Organic Farms Organic Nut l Mix, Raw; Certified Organic, USDA Organic. GMO Free, Peanut Free, Gluten Free Packed in 8 oz. 1 lb. 2. lb and 5 lb and 25 lb. clear or green standup bags. Ingredients: Organic Pistachios, Organic almonds, Organic Cashews, Organic walnuts. Braga Organic Farms, Madera, CA. Nut Mix: 8 oz., UPC: 896S47002177; Best by: JUL 06 2016, JUL 07 2016, JUL 11 2016, JUL 18 2016;; 1 lb., UPC: 810126020192; Purchased 12/28 to 1/27/6; 2 1bs, UPC: 896S47002351; Best by: JUL 01 2016, Purchased 12/28/15 to 1/27/16; 5 lbs., UPC: 810126020208, Purchased 12/28/15to 1/27/16; 25 lb. UPC: 896S47002412; Purchased 12/28/15 to  ...
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Class I IEH sample had a positive result for Salmonella in Braga Organic Pistachios Braga Organic Farms, Inc.
Devices Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO. Catalog # 180601 - Lot #'s: 26110111, 26300512-01, 26110112-01,  ...
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Class II Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier. Mako Surgical Corporation
Devices Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to support the upper and lower extremities immediately before, during and after fracture surgery. The Extension Device (1180.19F0) is a table top module for use with the Maquet MAGNUS operating table system and it is attached to the base mounting point of the MAGNUS operating table. Catalog Number 1180.19F0; Serial numbers 00003 and 00004. Class II MAQUET Medical Systems USA is initiating a field action for correction of the MAQUET Extension Device (Part No 1180.19F0). The Extension Device is manufactured by Maquet GmbH, in Germany, and is a table top module for use with the Maquet MAGNUS operating table system. Maquet GmbH was made aware of a potential issue that can result in the Extension Device becoming unlocked from the table top, causing it to fall down. Maquet Cardiovascular Us Sales, Llc
Biologics Source Plasma 41606652443; 41606714181; 41606825340; 41606676920; 41606675039 Class II Plasma products collected from a donor who did not meet acceptance criteria, were distributed. CSL Plasma, Inc.
Devices PINPOINT Endoscopic Fluorescence Imaging System Rev. J, Rev. K, Rev. L and Rev. M Model Number : PC9000 Class II It has been determined that the PINPOINT Operator's Manual does not contain validated parameters for gravity-cycle autoclave sterilization of the PINPOINT laparoscopes and light guide cable in the reprocessing tray. Novadaq Technologies Inc.
Drugs 0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product code 2F7123, NDC 0338-0048-03 Lot # G120162, Exp 11/18 Class II Presence of Particulate Matter: Product complaint for the presence of particulate matter identified as an insect Baxter Healthcare Corp.
Devices PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. This kit is used by clinicians to change dressings Kit #73775, Lot 213403 Class II Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit, which is not identified on the exterior labeling Medical Action Industries Inc
Devices Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them. REF numbers: PBKGB and PBKBG-10 (10 pack): all lots Class II Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date. Volcano Corporation
Devices Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them. REF numbers: 891BG and 891BG-10 (10 pack): all lots Class II Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date. Volcano Corporation
Devices Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I® H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures Catalog No. Lot Number UPN / GTIN BB8B09R4 209857492 00643169624436 BB8B09R4 210031260 00643169624436 BB8B09R4 210258522 00643169624436 BB8S23R 209685753 00643169624849 BB8S23R 209685754 00643169624849 BB8S23R 210141006 00643169624849 HY1W12R28 209821189 00643169620155 M273205G 210135065 00643169651258 M311110F 210007560 20643169409662 M311110F 210305334 20643169409662 M311110F 210646326 20643169409662 M311129K 210216215 00643169399280 M311129K 210637628 00643169399280 M311135D 210386285 00643169478183 M311136L  ...
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Class III Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS). Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I® H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. Medtronic Perfusion Systems
Devices Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3). Surgical Technique Manual L1637 Rev B (2014-06) Class II Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fixation System by providing additional guidance in the Virage OCT Surgical Technique Manual. Zimmer Spine, Inc.
Biologics Cornea CW113131OD; Class II Human cornea, 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, was distributed. Eye Bank Of Wisconsin, Inc.
Drugs Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Four vials per Carton, Carton contains 2 vials of Thyrogen and 2 vials of diluent, Storage: store at 2-8 C, Genzyme Corporation, Cambridge, MA 02142, NDC 58468-1849-04. Lot #: E4029Y02 (carton), E4029 (vial) Exp 09/2016 Class II Presence of Particulate Matter: Glass particles found in the product after reconstitution. Genzyme Corporation
Drugs Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Two vials per Carton, Carton contains 2 vials of Thyrogen, Dilute with Sterile Water for Injection, Storage: store at 2-8 C, Manufactured by: Genzyme Corporation, Northborough, MA 01532 USA, Marketing Authorization holder: Sanofi-Aventis, NDC 58468-0030-2. Lot #s: E4029Y03, E4029Y04, E4029Y06, E4029Y07, Exp 12/2017 Class II Presence of Particulate Matter: Glass particles found in the product after reconstitution. Genzyme Corporation
Devices Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant REF/Product Code/Art. No. 558521AN, Lot U29336 (exp. 10/5/2020); REF/Product Code/Art. No. 558520AN, Lots U33966, U35661, U50469 (exp. 10/5/2020) Class II Complaints were received claiming the material failed to polymerize under the curing light. After investigation, it was determined that a wrong photo-initiator was used in the production batch U30755 of Helioseal Clear. This failure can lead to incomplete curing of the sealant, if mono-wave LED curing lights are used. Ivoclar Vivadent, Inc.
Drugs sulfur8 medicated LIGHT FORMULA (sulfur) anti-dandruff hair & scalp conditioner, 2%, packaged in a) 2 OZ (57g) jar (UPC 0 75610 43510 8), and b) 4 OZ (113g) jar (UPC 0 75610 43610 5), 1 dozen jars per case, J. Strickland & Co., PO Box 1637, Olive Branch, MS 38654 Lot #: 33UF Class III Subpotent Drug: failed at the 3 and 6 month stability time points. J. Strickland and Co
Devices SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system 4522 131 5575x 4522 132 1985x 4522 132 7619x 4598 000 5187x 4598 000 5189x 4598 003 59051 Class II Wrong positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to coupling to the QBC. The combined use of the Sense coil, high SAR level scanning and placement of the cables contrary to instructions for use can lead to patient burns. Philips Electronics North America Corporation
Devices ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. Lot 1125585 (MIS-F707) Lot 11126021 (IS-7F11) Class II The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the size 11 product received 7 cm sheaths. Argon Medical Devices, Inc
Drugs Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 41616-638-68, UPC 3 41616 63868 4. Lot #s: JKP2234A, JKP2235A, Exp 04/17 Class II Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point. Sun Pharma Global Fze
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