2018 Product Recalls
5,529 recalls issued in 2018.
Showing 61–80 of 5,529 recalls
Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments.
The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) battery drawer on some BABY440 hearing aids. The correct battery drawer is tamper-resistant and require a special tool to open it.
The firm, Widex, sent an "Urgent Medical Device Correction Letter" dated 8/28/18 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: a) Investigate, whether your childs BABY440 hearing aid is mounted with the correct battery drawer. Please refer to the attachment How to determine if correct battery drawer is mounted. b) If affirmative, return the product to the hearing care professional, where you bought the hearing aid, to have the tamper-resistant battery drawer mounted. If you have any questions, contact Director, Global Regulatory Affairs at 0045 44 35 57 71 or email to: krpe@widex.com.
Block Heater Cable Splice Connector May Corrode
When the heater is plugged in, prolonged corrosion could cause a resistive short, increasing the risk of overheated or melted wiring which can increase the risk of a fire.
Ford will notify owners, and dealers will disable the block heater cable, free of charge. Once parts are available, Dealers will replace the engine block heater cable, free of charge. The recall began June 3, 2019. Owners may contact Ford customer service at 1-866-436-7332. Ford's number for this recall is 18S45.
Loose Front Suspension Fasteners
A loose front wheel may increasing the risk of a crash.
Volkswagen has notified owners, and dealers will inspect the front suspension fasteners, and replace them as necessary, free of charge. The recall began January 23, 2019. Owners may contact Audi customer service at 1-800-253-2834. Volkswagen's number for this recall is 40O2.
Navien condensing tankless water heaters and combinatio Recalled for Poisoning Hazard
A kit installed on the tankless water heaters and boilers to convert them from natural gas to propane can cause the unit to produce excessive amounts of carbon monoxide, posing a risk of carbon monoxide poisoning to consumers.
Consumers should immediately stop using the recalled water heaters and boilers that are using propane gas and contact Navien for a free replacement conversion kit. Consumers who continue use of the water heaters and boilers while awaiting repair, should have a working carbon monoxide alarm installed outside of sleeping areas in the home.
Valor H5 gas fireplaces Recalled for Fire Hazard
The trim around the fireplaces can leak hot exhaust air, posing a burn hazard.
Consumers should immediately stop using the recalled fireplaces and contact Miles Industries to schedule a free repair.
Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmitters have been connected to a central station. The anomaly causes some ECG waveforms to appear as a flat line at the centralized viewing station and will manifest if more than 64 TD60 transmitters have been connected to a given central station server. Each central station supports only 32 transmitters at a time. For the issue to manifest, the BeneVision DMS needs to be configured to use flexible device assignment, have more than 64 TD60 transmitters, and the workflow must allow 64 TD60s to move around between multiple central stations in the same care area.
The firm notified affected consignees on August 30, 2018, via Urgent Medical Device Recall letter. The letter advised customers of the software issue when more than 64 telemetry transmitters have been connected to a central station. Customers were advised to use the system normally, but informed that a Mindray Service Representative would be in contact to arrange for a system software update to be performed at the customer site. Mindrays Technical Support team may be reached at (877) 913-9663 (Option 1), Monday through Friday, 8:30am - 5:30pm ET should you have technical questions. Customers were also asked to complete and return an attached Acknowledgement and Receipt Form.
Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. UPC: 8 72320 00072 1 NDC 1406000304
cGMP violations noted during the firm's most recent inspection.
Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles (NDC 0378-6323-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Thyroid Powder, USP, 25kg/drum, Rx Only, Sichuan Friendly Pharmaceutical Co., LTD. NDC: 070870-1701-1
CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 90-count bottles (NDC 0093-7692-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottles (NDC 0378-6322-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1722-93.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5815-77.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5813-77.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1724-93.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1721-93.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1722-93.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Distributed by: Benco Dental, 295 Center Point Blvd., Pittston, PA 18640. NDC: 14060-01105
cGMP violations noted during the firm's most recent inspection.