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

Enforcement Report - Week of April 16, 2014

  • Print
  • Share
  • E-mail
-
Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Drugs Vicerex A Powerful And Fast Acting Male Sexual Enhancer, 10 capsules per box, Dietary Supplement. UPC 893490820087 (product numbers may possibly vary for same product identification and same product packaging), distributed by Vicerex.com. All lots, UPC 893490820087 Class I Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs. American Lifestyle.Com
Drugs Black Ant, 4600 mg x 4. Product is packaged in a small green box with gold lettering on the front, the back side of the box contains mostly foreign character. Within the box there are four (4) capsules individually wrapped in black and red plastic with white lettering. UPC 4026666142546 (product numbers may possibly vary for same product identification and same product packaging). All lots, UPC 4026666142546. Class I Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs. American Lifestyle.Com
Veterinary "CHAMPION LAMB TEXTURIZED B30 MEDICATED For GROWING AND FINISHING SHEEP***" Product Code 6701 LOT88021813 M392190 Class I A high level of Copper was discovered in the feed. CHS Nutrition
Drugs Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ, 85205. Lot #: 117433@15 Expiration Date: 12/07/2013 Lot #: 117446@8 Expiration Date: 12/12/2013 Lot#: 117923@8 Expiration Date: 12/19/2013 Class I Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination found in Calcium Gluconate saturated solution that was observed upon drawing the vial contents into a syringe. Zions RX Formulations Services LLC dba RX Formuations Serv.
Drugs Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205 Lot #: 117037@3 Expiration Date: 12/13/2013 Lot #: 117899@1 Expiration Date: 01/03/2014 Lot #: 118289@7 Expiration Date: 01/09/2014 Lot #: 118078@56 Expiration Date: 01/03/2014 Lot #:118394@29 Expiration Date: 01/09/2014 Lot #: 118338@10 Expiration Date: 01/09/2014 Lot #: 118056@46 Expiration Date: 01/02/2014 Class II Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm. Zions RX Formulations Services LLC dba RX Formuations Serv.
Drugs Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205 Lot #: 117467@9 Expiration Date: 12/12/2013 Lot #: 117857@2 Expiration Date: 12/15/2013 Lot #: 117740@4 Expiration Date: 12/13/2013 Class II Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm. Zions RX Formulations Services LLC dba RX Formuations Serv.
Drugs Oxytocin 30 Units in 500mL Sodium Chloride 0.9% Bags, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205 Lot #: 117440@1 Expiration Date: 12/27/2013 Lot #: 117901@2 Expiration Date: 01/03/2014 Lot #: 118291@32 Expiration Date: 01/05/2014 Lot #: 118392@28 Expiration Date: 01/09/2014 Lot #: 117659@66 Expiration Date: 12/26/2013 Lot #: 118348@17 Expiration Date: 01/09/2014 Lot #: 117601@38 Expiration Date: 12/26/2013 Lot #: 117847@13 Expiration Date: 12/29/2013 Lot #:  ...
More
Class II Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm. Zions RX Formulations Services LLC dba RX Formuations Serv.
Drugs Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205 a) Lot #: 117460@5 Expiration Date: 12/12/2013, Lot #: 117911@5 Expiration Date: 12/19/2013, Lot #: 118301@9 Expiration Date: 12/25/2013 b) Lot #: 117462@6 Expiration Date: 12/12/2013, Lot #: 117916@6 Expiration Date: 12/19/2013, Lot #: 118305@10 Expiration Date: 12/25/2013 c) Lot #: 118011@23 Expiration Date:  ...
More
Class II Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm. Zions RX Formulations Services LLC dba RX Formuations Serv.
Drugs Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205 Lot #: 117456@3 Expiration Date: 12/12/2013 Lot #: 117907@3 Expiration Date: 12/19/2013 Lot #: 118297@8 Expiration Date: 12/25/2013 Class II Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm. Zions RX Formulations Services LLC dba RX Formuations Serv.
Drugs Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205 a) Lot#118954@2 Exp. Date: 03/09/2014, Lot# 118917@2 Exp. Date: 03/06/2014; b) Lot #: 119379@24 Exp. Date: 01/19/2014, Lot#: 118815@27 Exp. Date: 03/03/2014 Class II Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm. Zions RX Formulations Services LLC dba RX Formuations Serv.
Food Prego Italian Sauce Traditional, NET WT. 24 OZ (1 LB. 80 Z.)(680 g) in glass jars. UPC 51000 2549 4, Expiration date JUN 16, 2015, Lid Codes JUN 16 2015 12153 CT BJ ZV 0330 through JUN 16 2015 12153 CT BJ ZV 0449 Class II Product may have become spoiled due to an elevated pH caused by dilute cleaning solution in the product. Campbell Soup Supply Co., LLC
Drugs Dr. Ming's Chinese Capsule (Ginger 50 mg, Camellia Sinensis 50 mg, Malus Domestica 50 mg, Propetary Blend 300 mg Cynara Scolymus, Hoodia, Siruline, Chitosan, 60-count bottles, Distributed by Natural Products, Doral, FL 33178. Lot #: 18 04 12, Exp 17 04 14 Class I Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug. Slim Beauty USA
Drugs Magic Slim capsules (Ling Zhi, Ebony, Fox-nut, Tuckahoe, Seman Pruni, Dioscoreae, Wheat Germ, Nature Substance), 60-count bottles. No lot code information or exp date on packaging. Class I Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug. Slim Beauty USA
Drugs Dream Body Slimming Capsule (Chinese bitter orange 24%, Cassia Seed 18%, Aloe 16%, Lotus Leaf Extract 12%, Medical Amylum 30%), 350 mg, 30-count bottles, Made in China (Beijing). Lot # 20130328, Exp 3/27/15 Class I Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutramine is not currently marketed in the United States, making this product an unapproved new drug. Slim Beauty USA
Food St. Mary's River Smokehouses Oven Smoked Atlantic Salmon Stix, Chili Mango Flavor UPC Code 6 26425 10092 9. Production code 347 31##, marked on a sticker on the end of the styrofoam tray. Class I Potential for Listeria monocytogenes contamination. Delhaize America (Hannaford Bros)
Food Evolution fresh Organic sweet Greens and Ginger, 15.2 fluid-ounce bottle, 6 bottles/case, UPC code is 762357378927. Enjoy by date of March 2, 2014. Class III Evolution Fresh is recalling Organic Sweet Green and Ginger Juice out of an abundance of caution. Evolution Fresh Inc
Veterinary 1/2cc Insulin Syringe U-40 with 29G x 1/2" Needles are individually packages in a container consisting of a transparent plastic bottom and a white top with green printing. 100 individual wrapped syringes per carton. The cartons are white with green printing. Catalog Number: MV1/2CCINS-40; Lot Number: 20120610 Class II The barrels on 1/2cc Insulin Syringe U-40 with 29G x 1/2" Needles are not marked correctly. The marking on the barrel indicate that 1/2cc of U40 insulin contains 40 units of insulin instead of 20 units of insulin. American Health Service Sales
Drugs etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single Dose Vials (NDC 0069-0006-02), 10 x 10 mL vials per carton (NDC 0069-0006-01) and b) 40 mg/20 mL (2 mg/mL) 20 mL Single Dose Vials (NDC 0069-0006-04), 10 x 20 mL vials per carton (NDC 0069-0006-03), Rx only, Distributed by Pfizer Labs; Division of Pfizer Inc., New York, NY 10017. Lot #: a) 5000983, 5000986, Exp 08/14; 5001023, Exp 09/14; b) 5000927, 5000931, 5000936, 5000942, 06/14; 5001012, 5001040, Exp 09/14; 5001071, Exp 10/14 Class II Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the potential for missing lot number and/or expiry date on the outer carton and the potential for illegible/missing lot number and expiry on individual vials. Agila Specialties Private Ltd.
Devices Playtex Nurser Deluxe Double Electric Breast Pump, Model X06578AO, powered by a 12V DC power supply, Model SY-12120, which is included with the package. Suspect date codes for Breast Pumps: P12324-91667C to P13205-30673C. Suspect adaptor date codes: 1241 to 1324. Class II Some of the power adapters outer casing may become loose and separate, resulting in a potential for electric shock. Energizer Personal Care
Food vitacost brand L-Citrulline Amino Acid 750 mg, 90 CAPSULES, DIETARY SUPPLEMENT, ITEM # NSI 3003310, UPC 8 35003 00331 0 --- Manufactured for Vitacost Lexington, NC 27295 Lot Nos. 1607500, 1612700, 1794500, 1810500,1937500, 2044500 Class II The product was produced using bulk L-Citrulline lot # 121109 which was subsequently recalled by the supplier since the lot was found to contain a compound other than L-Citrulline. Nature's Value Inc.
Food vitacost brand Men's Passion Booster, 30 Capsules, PREMIUM FORMULA DIETARY SUPPLEMENT, ITEM # NSI 3004713, UPC 8 35003 00471 3, and 120 CAPSULES, ITEM # NSI 3009473, UPC 8 35003 00947 3 --- Manufactured for Vitacost Lexington, NC 27295 30 capsules: Lot Nos. 1768600, 1783100, 2091200, 1979500; -- 120 capsules: Lot Nos. 1768600, 1646900, 1783100, 2050500, 2091200, 1979500 Class II The product was produced using bulk L-Citrulline lot # 121109 which was subsequently recalled by the supplier since the lot was found to contain a compound other than L-Citrulline. Nature's Value Inc.
Drugs Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901, Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0440-05 Lot #: F0126 Class III Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although the two products contain the same active ingredient, methylphenidate, the Medication Guides are not identical because the two products contain different excipients. Novartis Pharmaceuticals Corp.
Drugs Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901 Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0441-05 Lot #: F0131 Class III Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although the two products contain the same active ingredient, methylphenidate, the Medication Guides are not identical because the two products contain different excipients. Novartis Pharmaceuticals Corp.
Devices Syphilis Test Strip (Serum) LumiQuick, Santa Clara, CA 95054 Catalog number: 71015, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Syphilis Test Card Whole Blood(Serum) LumiQuick, Santa Clara, CA 95054 Catalog number: 71016, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Rickettsia IgG/IgM Test Card LumiQuick, Santa Clara, CA 95054 Catalog number: 71017, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Dengue IgG/IgM; LumiQuick, Santa Clara, CA 95054 Catalog number: 71019, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices H. Pylori Antigen Test Card LumiQuick, Santa Clara, CA 95054 Catalog number: 71020, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices H. Pylori Antibody Test Card (Whole Blood) LumiQuick, Santa Clara, CA 95054 Catalog number: 71024, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Salmonella typhi Antigen Test Card; LumiQuick, Santa Clara, CA 95054 Catalog number: 71028, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Rotavirus Test Card LumiQuick, Santa Clara, CA 95054 Catalog number: 71029, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Adenovirus Antigen Test Card; LumiQuick, Santa Clara, CA 95054 Catalog number: 71032, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Adeno/Rota Combo Test Card; LumiQuick, Santa Clara, CA 95054 Catalog number: 71033, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Legionella Test Card; LumiQuick, Santa Clara, CA 95054 Catalog number: 71034, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices H. Pylori Ab Test Card-Serum; LumiQuick, Santa Clara, CA 95054 Catalog number: 71046, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Strep A Test Card; LumiQuick, Santa Clara, CA 95054 Catalog number: 71048, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Malaria pf Antigen Test Card; LumiQuick, Santa Clara, CA 95054 Catalog number: 71049, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Malaria pf Antigen Test Card; Flumiquil, Santa Clara, CA 95054 Catalog number: 71050, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Malaria pan Antigen Test; LumiQuick, Santa Clara, CA 95054 Catalog number: 71053, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Salmonella typhi/paratyphi Antigen Test; LumiQuick. Santa Clara, CA 95054 Catalog number: 71054, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Salmonella typhi IgG/IgM Duo Test; LumiQuick. Santa Clara, CA 95054 Catalog number: 71055, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Syphilis Test Card (Serum); LumiQuick. Santa Clara, CA 95054 Catalog number: 71057, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Tuberculosis Antibody Test Card Serum; LumiQuick. Santa Clara, CA 95054 Catalog number: 71062, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Malaria pf/pan Antigen Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 71063, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Dengue NS1 Antigen Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 71066, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Dengue NS1 Ag/IgG/M Ab Duo Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 71087, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Fecal Occult Blood Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 72001, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices PSA Test Card (Serum); LumiQuick. Santa Clara, CA 95054 Catalog number: 72003, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices PSA Test Card (Whole Blood); LumiQuick. Santa Clara, CA 95054 Catalog number: 72004, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Fecal Occult Blood Test Strip; LumiQuick. Santa Clara, CA 95054 Catalog number: 72006, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Alcohol Test, Saliva; LumiQuick. Santa Clara, CA 95054 Catalog number: 74001, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Tramadol Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 74002, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Tramadol Strip; LumiQuick. Santa Clara, CA 95054 Catalog number: 74003, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Drugs of Abuse Panel Test Device; LumiQuick. Santa Clara, CA 95054 Catalog number: 74007, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Amphetamine Strip; LumiQuick. Santa Clara, CA 95054 Catalog number: 74013, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Amphetamine Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 74014, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Barbiturate Strip; LumiQuick. Santa Clara, CA 95054 Catalog number: 74015, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Barbiturate Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 74016, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Benzodiazepine Strip; LumiQuick. Santa Clara, CA 95054 Catalog number: 74017, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Benzodiazepine Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 74018, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Cocaine Strip; LumiQuick. Santa Clara, CA 95054 Catalog number: 74019, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Cocaine Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 74020, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices EDDP Strip; LumiQuick. Santa Clara, CA 95054 Catalog number: 74021, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices EDDP Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 74022, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices MDMA/Ecstasy Strip; LumiQuick. Santa Clara, CA 95054 Catalog number: 74023, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices MDMA/Ecstasy Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 74024, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Methadone Test Strip; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74025, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Methadone Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 74026, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Methamphetamine Strip; LumiQuick, Santa Clara, CA 95054 Catalog number: 74027, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Methamphetamine Test Card; LumiQuick, Santa Clara, CA 95054 Catalog number: 74028, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Morphine Strip (300); LumiQuick, Santa Clara, CA 95054 Catalog number: 74029, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Morphine Test Card (300); LumiQuick, Santa Clara, CA 95054 Catalog number: 74030, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Morphine Strips (2000); LumiQuick, Santa Clara, CA 95054 Catalog number: 74031, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Morphine Test Card (2000); LumiQuick, Santa Clara, CA 95054 Catalog number: 74032, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices PCP Test (Strip); LumiQuick, Santa Clara, CA 95054 Catalog number: 74033, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices PCP Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 74034, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices THC Strip; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74035 All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices THC Test Card; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74036 All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Ketamine Strip; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74039 All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Ketamine Test Card; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74040 All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Buprenorphine Test Strip; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74041 All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Buprenorphine Test Card; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74042, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Oxycodone Strip; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74043, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Oxycodone Test Card; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74044, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Alcohol Test, Urine; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74049, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Propoxyphene Test Strip; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74051, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Propoxyphene Test Strip; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74052, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Methylphenidate Test Strip; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74055, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Methylphenidate Test Card; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74056, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Fentanyl Test Strip; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74057, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74058, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74059, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Clonazepam Test Card; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74060, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices K2 (synthetic Marijuana) Test Strip; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74065, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices K2 (synthetic Marijuana) Test card; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74066, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Troponin I test Card (serum); LumiQuick,. Santa Clara, CA 95054 Catalog number: 75001, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Troponin I test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 Catalog number: 75002, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Cardiac Panel Test (Serum); LumiQuick,. Santa Clara, CA 95054 Catalog number: 75003, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Cardiac Panel Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 Catalog number: 75004, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Myoglobin Test Card (Serum); LumiQuick,. Santa Clara, CA 95054 Catalog number: 75005, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Myoglobin Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 Catalog number: 75006, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices CK-MB Test Card (serum); LumiQuick,. Santa Clara, CA 95054 Catalog number: 75007, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices CK-MB Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 Catalog number: 75008, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. LumiQuick Diagnostics Inc.
Devices Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod. Lot #: 130424-15 (only laser marked on the Part Number: M040-SS-110); Lot #: 121109-11 &130424-15 [Indicated on the label of the Catalogue Number: FD-040(L)-SS]. Class II The Male Components in this lot are made of material with lower strength than manufacturing specifications. Pega Medical Inc.
Devices Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833 Oxylog 3000 plus, Part number: 5704833 with serial numbers: ASEK-0003, ASEK-0004, ASEK-0005 Class I The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm and displays the error message Poti unplugged. Draeger Medical Systems, Inc.
Devices GLOBAL® Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnson Product Usage: Usage: The GLOBAL APG+ 2.5mm Guide Pin is a single-use instrument that is used to assist the surgeon in the orientation of the cannulated reamer(s) and cannulated central drills in the preparation of the glenoid surface. The GLOBAL APG+ 2.5mm Guide Pin is validated for use with the GLOBAL APG+, GLOBAL STEPTECH APG, and DELTA XTEND Systems. The guide pin is scored in three locations, which allows the surgeon to select a desired pin length. The single-use shoulder instrument is made from 316L Stainless Steel. Label Lot Laser Lot D38FX4 PG0809 D5AA34 PG1009 D5AA44 PG1109 E1WC14 PG0710 E1WC24 PG0710 E1WC34 PG0810 E1WC44 PG0810 E1WCY4 PG0710 E24A44 PG0810 E24A54 PG0810 E28CB4 PG0810 E29G14 PG1210 E2FCW4 PG0810 E2FCX4 PG0810 E2FCY4 PG0810 E2VB24 PG0910 E2VB34 PG0810 E2VB44 PG0810 E2VB54 PG0910 E2VB64 PG0910 E2VB74 PG1010 E41E44 PG1010 E41E54 PG1010  ...
More
Class II Urgent Device Correction notifications are being sent to USA distributors with follow-up to surgeons concerning updated surgical techniques stressing the possibility of the shoulder pin guide breaking and potentially being left in the patient. DePuy Orthopaedics, Inc.
Devices Smiths Medical HOTLINE® Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions 2509489 2509490 2509491 2509491 2509493 2513256 2513257 2513258 2513259 2513259 2523835 2528502 2528503 2528505 2531609 2531609 2536970 2536971 2536972 2540530 2540531 2540531 2540533 2540534 2540535 2540536 2540537 2540537 2549516 2553479 2553480 2553481 2558317 2558317 2558324 2563120 2563123 2567637 2567638 2567638 2567640 2572571 2573607 2576408 2577526 2577526 2585112 2585113 2586060 2588651 2588652 2588652 2590076 2597393 2597394 2600985 2602457 2602457 2602460 2607387 2607389 2607390 2610674 2610674 2614827 2615844 2615845 2615846 2620953 2620953 2620957 2621091 2621096 Class II Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged. Smiths Medical ASD, Inc.
Devices Smiths Medical HOTLINE® Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions 2513261 2531612 2540540 2545044 2588656 Class II Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged Smiths Medical ASD, Inc.
Drugs Pleo Not OINTMENT 3X, 30 g Tube, Topical Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2305-1. Batch # 03051, EXP: April 2014; Batch # 13072, EXP: June 2015; Batch #21033, EXP: April 2016. Class II Penicillin Cross Contamination Terra-Medica Inc.
Drugs Pleo Not SUPPOSITORIES 3X, 10 Suppository Cartons, Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2304-1. Batch # 1080, EXP: July 2015; Batch # 1102, EXP: Septempber 2017. Class II Penicillin Cross Contamination Terra-Medica Inc.
Drugs Pleo Not CAPSULES 4X, 20 Tablet Cartons, Oral Homeopathic Fever Reducer/ Cough Suppressant/ Decongestant Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2303-1. Batch # 14010, EXP: December 2014; Batch # 11080, EXP: August 2015; Batch # 12092, EXP: July 2017. Class II Penicillin Cross Contamination Terra-Medica Inc.
Drugs Pleo Not TABLETS 5X, 20 Tablet Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2302-1. Batch # 15070, EXP: June 2015; Batch # 24072, EXP: June 2017. Class II Penicillin Cross Contamination Terra-Medica Inc.
Drugs Pleo Not DROPS, 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2301-1. Batch # 21049, EXP: March 2014; Batch # 13059; EXP: April 2014; Batch # 09080, EXP: July 2015; Batch #15100; EXP: September 2015; Batch # 24092; EXP: August 2017. Class II Penicillin Cross Contamination Terra-Medica Inc.
Drugs Pleo Not PORTABLE SIPS, 5X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-1. Pleo Not PORTABLE SIPS, 5X, 50 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-2. (10 x 1mL): Batch # 07099, EXP: August 2014; Batch # 15090;  ...
More
Class II Penicillin Cross Contamination Terra-Medica Inc.
Drugs Pleo Not PORTABLE SIPS, 6X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-1. Pleo Not PORTABLE SIPS, 6X, 50 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-2 . (10 x 1mL) Batch # 25050, EXP: April 2015. (50 x 1mL): Batch # 25050, EXP: April 2015. Class II Penicillin Cross Contamination Terra-Medica Inc.
Drugs Pleo Not PORTABLE SIPS 7X,10 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-1. Pleo Not PORTABLE SIPS 7X, 50 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-2. (10 x 1 mL) Portable Sips: Batch # 20010, EXP: December 2014. (50 x 1ml) Portable Sips: Batch # 20010, EXP: December 2014. Class II Penicillin Cross Contamination Terra-Medica Inc.
Drugs Pleo Nota- Quent DROPS 5X, 10 mL Bottles, Homeopathic Medicine, OTC Only. Made in Germany, Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, Hoya, Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. NDC: 49807-0031-1. Batch #04062 , EXP: May 2017; Batch #06062 , EXP: May 2017. Class II Penicillin Cross Contamination Terra-Medica Inc.
Drugs Pleo Quent SUPPOSITORIES 3X, 10 Suppository Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2904-1. Batch # 2089; EXP: June 2014; Batch #3031 , EXP: June 2016. Class II Penicillin Cross Contamination Terra-Medica Inc.
Drugs Pleo Quent CAPSULES 4X, 20 Capsule Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG NDC: 49807-2902-1. Batch # 25030; EXP: April 2015; Batch # 27101, EXP: Sept 2016. Class II Penicillin Cross Contamination Terra-Medica Inc.
Drugs Pleo Quent DROPS 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2901-1. Batch # 15129; EXP: November 2014; Batch #12040, EXP: March 2015; Batch #01081, EXP: August 2016. Class II Penicillin Cross Contamination Terra-Medica Inc.
Drugs Pleo Quent PORTABLE SIPS 5X, 10 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-1. Pleo Quent PORTABLE SIPS 5X, 50 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-2. 10 x 1 ml: Batch # 13090; EXP: August 2015. 50 x 1 ml: Batch #13090, EXP: August 2015. Class II Penicillin Cross Contamination Terra-Medica Inc.
Drugs Pleo Fort SUPPOSITORIES 3X, 10 Suppository Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1106-1. Batch # 3110; EXP: October 2015; Batch # 1112; EXP: October 2017. Class II Penicillin Cross Contamination Terra-Medica Inc.
Drugs Pleo Fort CAPSULES 4X, 20 Capsule Cartons Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1103-1. Batch # 24030; EXP: February 2015; Batch # 14062; EXP: May 2017. Class II Penicillin Cross Contamination Terra-Medica Inc.
Drugs Pleo Fort PORTABLE SIPS 5X, 10 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1105-1. Pleo Fort PORTABLE SIPS 5X, 50 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1105-2. 10 x 1 ml Cartons: Batch # 15030; EXP: February 2015; Batch # 12122; EXP: November 2017. 50 x 1 ml: Batch # 15030; EXP: February 2015; Batch # 12122; EXP: November 2017. Class II Penicillin Cross Contamination. Terra-Medica Inc.
Drugs Pleo-Fort DROPS 5X, 10ml bottle, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1101-1. Batch # 23109; EXP: September 2014; Batch # 08030; EXP: February 2015; Batch # 12032; EXP: February 2017; Batch # 26043; EXP: March 2018. Class II Penicillin Cross Contamination Terra-Medica Inc.
Drugs Pleo Fort TABLETS 5X, 20 Tablet Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1102-1. Batch # 27100; EXP: September 2015; Batch # 29100; EXP: October 2015; Batch # 25013; EXP: January 2018. Class II Penicillin Cross Contamination Terra-Medica Inc.
Drugs Pleo Ex SUPPOSITORIES 3X, 10 Suppository Packages; Homeopathic Antifungal Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1001-1. Batch # 2011; EXP: December 2015; Batch # 2081, EXP: July 2016; Batch # 3063, EXP: May 2018; Batch # 1013, EXP: February 2018. Class II Penicillin Cross Contamination Terra-Medica Inc.
Drugs Pleo Ex DROPS 5X, 10 ml bottles, Homeopathic Antifungal Medicine, OTC Only. Made in Germany for: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GMbH & Co. KG. NDC: 49807-1003-1. Batch # 07011; EXP: December 2015; Batch # 09043, EXP: March 2108. Class II Penicillin Cross Contamination Terra-Medica Inc.
Drugs Pleo Ex PORTABLE SIPS 5X, 10 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-1. PLEO--EX Portable Sips 5X, 50 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-2. 10 x 1 mL: Batch # 09020; EXP: January 2015; Batch # 03052, EXP: April 2017. 50 x 1 mL: Batch # 09020; EXP: January 2015; Batch # 03052, EXP: April 2017. Class II Penicillin Cross Contamination Terra-Medica Inc.
Drugs Pleo Stolo DROPS 6X, 10ml Bottle; Homeopathic Anti-Inflammatory Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-0011-1. Batch # 08060; EXP: May 2015; Batch # 07119, EXP: August 2014; Batch # 03043, EXP: May 2018. Class II Penicillin Cross Contamination Terra-Medica Inc.
Devices Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control Product Usage: Is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. Product Part Number: 501-605 Lot# 1311-682 Exp. 3/26/2014 501-607 Lot# 1311-683, 1311-684 Exp. 3/26/2014 501-608 Lot# 1311-683 Exp. 3/26/2014 Class II Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots. Clinical Diagnostic Solutions
Food Enhanced Bali Leaf Powder, Max Kratom, Capsule, UPC Code 5410600332, 20 count pack, 5 servings per pack, Herbal Dietary Supplement. UPC Code 5410600332 Class II Smiley National is voluntarily recalling all lots of Bali Kratom 40, XL Kratom, Maeng da Kratom, and Max Kratom due to the presence of unapproved dietary ingredients. Smiley National Inc
Food Enhanced Maeng Da Leaf Powder, Maeng Da Kratom, capsule, UPC code 5410600330, 10 Pack, 2 Servings Per Pack, 10 grams. UPC code 5410600330 Class II Smiley National is voluntarily recalling all lots of Bali Kratom 40, XL Kratom, Maeng da Kratom, and Max Kratom due to the presence of unapproved dietary ingredients. Smiley National Inc
Food All Natural, XL Kratom, Herbal Dietary Supplement, capsule, UPC code 5410600307, 4 capsules per package. UPC code 5410600307 Class II Smiley National is voluntarily recalling all lots of Bali Kratom 40, XL Kratom, Maeng da Kratom, and Max Kratom due to the presence of unapproved dietary ingredients. Smiley National Inc
Food Natural Bali Kratom 40, capsule, UPC code 5410600335, 20 capsules per bottle. UPC code 5410600335 Class II Smiley National is voluntarily recalling all lots of Bali Kratom 40, XL Kratom, Maeng da Kratom, and Max Kratom due to the presence of unapproved dietary ingredients. Smiley National Inc
Food The Other Macaroon G'nache P'nache 5.3 oz. Manufactured and Distributed by:Northern Valley Baking Co LLC, Dumont, New Jersey USA LOT #: 338B009C, 338B010C, 007C015C, 007C016C, 013C014C, 007C016C, 007C020C, 007C021C Class II Northern Valley Baking Company did not declare milk or soy on the allergen statement of G'nache P'nache. Northern Valley Baking Co.
Drugs Demerol, meperidine HCL Inj. USP, 25 mg/0.5 mL (50 mg/mL), 0.5 mL ampoules, Rx only, NDC 0409-1203-01, Hospira, Inc., Lake Forest, IL. Lot: 221303A, 1OCT2014 Class III Labeling; Missing label; ampoules are missing the immediate container label Hospira Inc.
Devices FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical extension cable intended to transmit signal from, or power or excitation signal to patient connected electrodes. The cable is a sterile, disposable device. Lot numbers 131901, 132262, 132263, 132533, 132693, 132694, 132833 132835, 132986, and 133171. Class II Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically, the polarity for the black chuck in the picture is wrong. It shows (+), but should show (-). Remington Medical Inc.
Devices Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation. (US) Serial Numbers: 0311-A007, 0511-A013, 0611-A017, 0611-A018, 0711-A021, 0811-A026, 0811-A027, 0811-A033, 0811-A035, 0911-A039, 0911-A045, 1011-A050, 1011-A062, 1111-A067, 1111-A073, 1111-A077, 1111-A080, 1111-A085, 1211-A086, 1211-A087, 1211-A088, 1211-A090, 0112-A099, 0212-A111, 0212-A116, 0212-A117, 0312-A126, 0312-A130, 0312-A135, 0412-A147, 0412-A152, 0412-A153, 0412-A155, 0512-A163, 0512-A167, 0512-A169. (International) Serial Numbers: 0611-A020, 0711-A022, 0711-A025, 0811-A030, 0811-A031, 0811-A032, 0811-A037, 0911-A038, 0911-A040, 0911-A041, 0911-A042, 1011-A053, 1011-A054, 1011-A055, 1011-A060, 1111-A069, 1111-A071, 1111-A072, 1111-A074, 1111-A075, 1111-A081, 1111-A082, 1211-A091, 1211-A094, 0112-A106, 0112-A107, 0112-A108, 0112-A109, 0212-A118, 0312-A121, 0312-A122, 0312-A123, 0312-A127, 0312-A132, 0512-A158, 0512-A160, 0512-A162, 0512-A164, 0512-A166. Class II Alcon LenSx received reports of unexpected downward motion of the gantry. Alcon LenSx, Inc.
Food Fannie May Assorted Chocolates Rich dark & milk chocolate & pastels with an assortment of decadent fillings NET WT 14 OZ (396 g) Assorted Chocolates Nutrition Facts:***Ingredients: SUGAR, MILK CHOC LATES***CONTAINS: EGGS, MILK, SOY, TREE NUTS. WHEAT, GLUTEN***Distributed By: Fannie May Confections Brands, Inc., Chicago, IL 60160 www.fanniemay.com" UPC 0 52745 72804 6 Lot #14058 & Lot # 14059 Class I The product is being recalled due to an undeclared allergen of peanuts in the ingredient statement. Fannie May Confection Brands Inc
Devices 7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage Product Number 310006 Class II The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. Aspen Surgical Products, Inc.
Devices 10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage Product Number 310007 Class II The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. Aspen Surgical Products, Inc.
Devices 10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drainage Product Number 310017 Class II The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. Aspen Surgical Products, Inc.
Devices 15FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drainage Product Number 310018 Class II The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. Aspen Surgical Products, Inc.
Devices Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems Product Number 310100 Class II The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. Aspen Surgical Products, Inc.
Devices Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems Product Number 310101 Class II The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. Aspen Surgical Products, Inc.
Devices 7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage Product Number 322205 Class II The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. Aspen Surgical Products, Inc.
Devices 10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage Product Number 332263 Class II The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. Aspen Surgical Products, Inc.
Devices 15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage Product Number 332264 Class II The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. Aspen Surgical Products, Inc.
Devices 19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage Product Number 332265 Class II The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. Aspen Surgical Products, Inc.
Devices 10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage Product Number 340001 Class II The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. Aspen Surgical Products, Inc.
Devices 10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage Product Number 340003 Class II The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. Aspen Surgical Products, Inc.
Devices 10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage Product Number 340005 Class II The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. Aspen Surgical Products, Inc.
Devices 7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage Product Number 340006 Class II The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. Aspen Surgical Products, Inc.
Devices 10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage Product Number 340007 Class II The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. Aspen Surgical Products, Inc.
Devices 15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage Product Number 340018 Class II The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. Aspen Surgical Products, Inc.
Devices 19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case) Intended for closed wound suction drainage Product Number 340019 Class II The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. Aspen Surgical Products, Inc.
Devices 7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage Product Number 340002 Class II The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. Aspen Surgical Products, Inc.
Devices 7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage Product Number 340004 Class II The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. Aspen Surgical Products, Inc.
Devices 5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation,clip- ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators,monopolar cautery, bipolar cautery, 5mm curved cannulae,5mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port. Part number 428061-03: Lot numbers: VE105001 VE120201 VE121301 VE121803 VE122502 VE123106 VE105002 VE120301 VE121304 VE121907 VE122605 VE111201 VE120503 VE121403 VE122002 VE122606 VE114501 VE120703 VE121508 VE122101 VE122902 VE114601 VE121002 VE121605 VE122203 VE123006 VE115201 VE121112 VE121701 VE122401 VE123104. Class II Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use. Intuitive Surgical, Inc.
Devices 5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation,clip- ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators,monopolar cautery, bipolar cautery, 5mm curved cannulae,5mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port. Part number 428062-03: Lot numbers: VE105003 VE120304 VE121402 VE121903 VE122704 VE123101 VE111202 VE120402 VE121502 VE121905 VE122705 VE123103 VE114502 VE120504 VE121506 VE122201 VE122707 VE123105 VE114602 VE120902 VE121512 VE122202 VE122903 VE115202 VE121003 VE121606 VE122303 VE123005 VE120202 VE121113 VE121702 VE122501 VE123012. Class II Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use. Intuitive Surgical, Inc.
Devices 5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation,clip- ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators,monopolar cautery, bipolar cautery, 5mm curved cannulae,5mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port. Part number 428071-03: Lot numbers: VE113001 VE121004 VE121205 VE122004 VE122604 VE123014 VE113401 VE121007 VE121407 VE122005 VE122901 VE123107 VE114001 VE121103 VE121410 VE122104 VE122904 VE123202 VE114401 VE121105 VE121604 VE122204 VE122908 VE120602 VE121109 VE121608 VE122302 VE122911 VE120701 VE121110 VE121804 VE122403 VE123007. Class II Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use. Intuitive Surgical, Inc.
Devices 5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation,clip- ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators,monopolar cautery, bipolar cautery, 5mm curved cannulae,5mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port. Part number 428072-03: Lot numbers: VE113001 VE121005 VE121204 VE121904 VE122404 VE123008 VE113402 VE121008 VE121406 VE121906 VE122607 VE123013 VE114002 VE121104 VE121507 VE122102 VE122706 VE114402 VE121106 VE121511 VE122103 VE122905 VE120603 VE121111 VE121609 VE122301 VE122909 VE120702 VE121203 VE121708 VE122402 VE122912. Class II Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use. Intuitive Surgical, Inc.
Food Wing Bran-Bkrs 40# 30/PAL720600, #14535 , Contains Wheat 40.00 lbs (18.14 kg), UPC 7 96800 72060 5, Ingredients Wheat Bran. Wingold Bran - Bakers 40#720500, Contains Wheat 40.00 lbs (18.14 kg), UPC 7 96800 72050 6, Ingredients What Bran. Lot #'s W021014, W021114, W021214, W021314, W021414, W021714, W021814, VV021914, VV0220 14, W022114, W022414, W022514, VV022614, W022714, W030114, W030314, W030614. Class II Bay State Milling Company is recalling select lot codes of bran produced in its Winona, MN mill between February 10, 2014 and March 7, 2014. The decision to voluntarily recall the product is based upon findings of metal fragments in the product. Bay State Milling Company
Devices Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids. not applicable Class II The Initial Cassette Volume Check (ICVC) is not activated on the cobas c 502 module of the cobas® 8000 modular analyzer series when manually filled cobas c packs are loaded. This issue occurs with tests that use cobas c pack MULTI or empty pre-labeled cobas c packs. The ICVC feature allows the reagent probe to dive into the reagent cassette and confirm the reagent level in the bottles. This ensures that manually filled cassettes are at the proper level. Roche Diagnostics Operations, Inc.
Drugs Rantidine Tablets USP, 150 mg, 500-count bottles, Rx only, Manufactured by: Shasun Pharmaceuticals Limited, Unit-II R.S. No 32 33 & 34, Shasun Road, Periyakalapet, Puducherry, - 605 014, India; Manufactured for: Glenmark Generics Inc, USA, Mahwah, NJ 07430, UPC 3 68462 24805 8, NDC 68462-248-05. Lot 12AN118A, Exp 10/14 Class II Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg. Glenmark Generics Inc., USA
Drugs Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotropium) per capsule, Rx Only, a) NDC 0597-0075-75, 5 Spiriva capsules per blister card, b) NDC 0597-0075-41, 30 Spiriva capsules per blister card, Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany, Marketed by: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06877 USA and Pfizer Inc New York, NY 10017 USA, Made in Germany. a) 5 count capsule blister card: 303012A, Exp Sep 2014; b) 30 count capsules blister card: 303012B, Exp Sep 2014, 303125A, 303253A, Exp Oct 2014, 303895A, 304282A, Exp Nov 2014, 304510A, Exp Dec 2014 Class III Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell. Boehringer Ingelheim Roxane Inc
Devices 400003 Medcare Lift with Scale 400013 Medcare Lift w/Scale 600 lb 400600 Scale Hanger Assembly Product Usage: The intended use is a patient hanger bar (400600) attached to a 400003 or 400013 floor lift used to lift, transfer or position clients. Serial # 0810LS1522 0810LS1523 0910LS1524 0910LS1525 0910LS1526 0910LS1527 0910LS1528 0804LS0854 0910LS1529 0910LS1530 1010LS1532 0910LS1531 1010LS1533 1010LS1534 1010LS1535 1010LS1536 1010LS1537 1010LS1538 1010LS1539 1010LS1540 1010LS1541 1010LS1542 1010LS1543 1010LS1544 1010LS1545 1010LS1546 1010LS1547 1010LS1548 1110LS1549 1201LS1551 1210LS1550 1210LS1552 1210LS1553 1210LS1554 1210LS1555 1210LS1556 1210LS1557 0111LS1558 0111LS1561 0111LS1560 0111LS1562 0111LS1563 0111LS1564 0111LS1565 0111LS1566 0111LS1567 0111LS1559 0111LS51559  ...
More
Class II MedCare Products has determined that a number of their Floor Lifts manufactured from 9/1/2010 to 11/7/2012 do not meet MedCare's high standards. The original design includes a pin that over time and years of use may stop performing as designed and may break. ErgoSafe Product LLC dba Prism Medical Services
Devices Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets. Product Usage: The breathing bag is a component of the anesthesia set (breathing circuit) that is intended to is the conduit for administering medical gases to a patient during ventilation. It provides both an inspiratory and expiratory route. 2. The test lung is an apparatus that contains a breathing bag and and connector. It is connected to the output of a ventilator and is used as part of the device/system check out. Reusable latex breathing bags with part numbers 2165686, 2165953, 2165694, as part of test lung part number 8403201, and reusable anaesthesia sets part numbers M33681 and M27542. Class II Reusable latex breathing bags with various part numbers and sold as part of test lung and reusable anaesthesia sets were recalled when Draeger became aware of an incident where a user suffered an acute allergic reaction after using a Dräger latex test lung. The user did not suffer permanent injury. The breathing bag that belongs to the test lung and other latex breathing bags are labelled NR. Although this is the standard abbreviation for natural rubber (latex), CFR 21 Part 801 Sec. 801.437 requires additional language. It is unclear whether the labelling of the product played any part in the reported incident. Draeger Medical, Inc.
Food Orton Bros. Brand Zesty Lemon Cookie Buttons; 6 oz. yellow box, UPC code 20104 19100. The lot code and expiration date are stamped on the bottom of the box; LOT14021M with the expiration date of 10-21-14. The lot code and expiration date are stamped on the bottom of the box; LOT14021M with the expiration date of 10-21-14. Class I Undeclared peanuts. Vermont Common Foods, LLC
Devices Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support. Lot No. 705764 Class II Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label. Breg Inc
Devices K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support. Lot No. 705593 Class II Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label. Breg Inc
Food Hard Blast Pink Lemonade Net Wt. 19 oz. Developed and exclusively distributed by: TBI Labs LLC, Miami, FL 33137 www.tbilabs.com 888-253-0958 Made in USA UPC 628586182561 Lot 13075 Exp. Date 4/29/2015 Class II Command Nutritionals LLC is recalling Hard Blast-Pink Lemonade and Juggernaut- Various flavors due to contaminated L-Citrulline which was received from Axel Chemicals, Brentwood, TN. Command Nutritionals, LLC
Food Juggernaut a) Crimson Punch UPC 811020906803 b) Orange UPC 811020906841 c) Raspberry Lemonade UPC 811020906858 Net Wt. 1.76 lbs. Manufactured in the USA Infinite Labs, LLC PO Box 533736 Orlando, FL 32853 1-877-455-2271 a) Crimson Punch - Lot #13086 - exp date 04/01/2015 b) Orange - Lot #13085 - exp date 04/01/2015 c) Raspberry Lemonade - Lot #13087 - exp date 01/01/2015 Class II Command Nutritionals LLC is recalling Hard Blast-Pink Lemonade and Juggernaut- Various flavors due to contaminated L-Citrulline which was received from Axel Chemicals, Brentwood, TN. Command Nutritionals, LLC
Food i heart keenwah Chocolate Sea Salt All Natural Quinoa Clusters. UPC 736211802446 for the 4 oz UPC 713757598101 for the 1 oz All codes which read EXPDDMMYY (all dates) Class II An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of i heart keenwah, quinoa clusters and soy was not declared on the product labeling. keen-wah LLC
Food i heart keenwah Almond All Natural Quinoa Clusters. UPC 736211802347 for the 4 oz UPC 713757598200 for the 1 oz All codes which read EXPDDMMYY (all dates) Class II An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of i heart keenwah, quinoa clusters and soy was not declared on the product labeling. keen-wah LLC
Food i heart keenwah Ginger Peanut All Natural Quinoa Clusters. UPC 736211802644 for the 4 oz UPC 713757598408 for the 1 oz All codes which read EXPDDMMYY (all dates) Class II An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of i heart keenwah, quinoa clusters and soy was not declared on the product labeling. keen-wah LLC
Food i heart keenwah Cranberry Cashew All Natural Quinoa Clusters. UPC 736211802545 for the 4 oz UPC 713757598309 for the 1 oz All codes which read EXPDDMMYY (all dates) Class II An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of i heart keenwah, quinoa clusters and soy was not declared on the product labeling. keen-wah LLC
Food i heart keenwah Peanut Butter Cacao All Natural Quinoa Clusters. UPC 736211884442 - 4 oz 12 units/cs All codes which read EXPDDMMYY (all dates) Class II An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of i heart keenwah, quinoa clusters and soy was not declared on the product labeling. keen-wah LLC
Devices Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 automatic external defibrillator. Serial Numbers: USN1307680 USD1309181 USD1308456 USD1309182 USD1309167 USD1309184 USD1309168 USD1309194 USD1309180 USD1309195 USD1309196 USD1309274 USD1309197 USD1309286 USD1309227 USD1309301 USD1309264 US11409686 USD1309269 Class II A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy Philips Medical Systems, Inc.
Devices Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator. USO1100106 to USO1100372 USN1100376 to USN1100960 USD1100961 to USD1101095 US11201096 to US11201186 US21201187 to US21201239 US31201240 to US31201537 US41201538 to US41201585 US51201586 to US51201721 US61201722 to US61201924 US71201925 to US71202048 US81202049 to US81202168 US91202169 to US91202514 USO1202515 to USO1202990 USN1202991 to USN1203537 USD1203538 to USD1203968 US11303969 to US11303972 US21303980 to US21304488 US31304489 to US31305042 US41305043 to US41305295 US51305296 to US51305450 US61305451 to US61306138 US71306139 to US71306542 US81306543 to US81306998 US91306999 to US91307261 USO1307306 to USO1307458 USN1307616 to USN1308423 USD1308424 to USD1309471 US11409472 to US11410212 US21410213 to US21410563 Class II Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay in therapy. Philips Medical Systems, Inc.
Devices Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less. SKU/Item Number 66838, Sold June 2009 to March 2014. Class II Harbor Freight Tools intiaited a recall of Sit/Stand Rolling Walker (SKU/Item Number 66838, sold June 2009 to March 2014) because, over time, there is the possibility that a walker wheel may come off this product following repeated use without tightening the wheel bolt to the frame, presenting a potential hazard for the user. Central Purchasing LLC DBA Harbor Freight Tools
Food Diced Dry Bean Curd. Manufactured by: E Won Trading Company, LTD. Distributed by: Win Luck Trading Co. LLC, 100 Pulaski Street, Bayonne, NJ 07002. UPC 4716670715248. 10.58 oz (300g) plastic bag. UPC 4716670715248 Class II The recall was initiated after it was discovered that the product contains unallowed dye:16255-Ponceau 4r(E124) Acid Red 18 and undeclared FD&C Yellow # 6. Lam Sheng Kee (Usa) Enterprise C
Show all Code Info
-
-