Class I - Dangerous
Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops.
Owens & Minor Distribution
8 recalls • • Categories: Other Medical Devices, Surgical Instruments, Infusion Pumps
Class I - Dangerous
Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection
Owens & Minor is the initial importer and private label distributor of Medi Choice Arm Slings (Product). The Product is manufactured in China by Tops Medical Articles Nantong Inc. Owens & Minor first learned of the product issue that prompted the product removal action via customer complaints received in September 2016. Two customer complaints received on September 1"1, 2016 reported surface contamination on the arm slings. Two additional complaints reported on September 19, 2016 and October 7, 2016 reported the same issue. Upon receipt of the complaints on September 1, 2016, Owens & Minor immediately initiated a CAPA investigation for root cause analysis and determination of corrective/preventive actions. A quality inspection of inventory confirmed that the surface contamination was confined to lots manufactured in May, June, and July of 2016. The surface contamination for these lots was found to be frequent. Subsequent August product lots were inspected and no surface contamination was found. Limited inventory from lots prior to May 2016 were available and inspected as well. No surface contamination was found on these prior lots. Owens & Minor has quarantined the affected product lots. The product is on hold at all Owens & Minor Distribution Centers (DC). Samples of contaminated product have been sent to the manufacturer for evaluation and to a certified testing lab for identification of contaminate. These results are pending at this time. Based on the frequency of the product defect as well as evaluation of potential adverse health event risk, Owens & Minor initiated a voluntary recall for the above stated affected product lots.
Class I - Dangerous
MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination.
Class I - Dangerous
MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination.
Class I - Dangerous
MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination.
Class I - Dangerous
Product wheels may be too loose, too tight, or fall off.
Owens & Minor Distribution, Inc. is conducting a market withdrawal of MediChoice Applicator OB-GYN 8 inch product that does not meet our quality standards because the rayon may loosen or unravel from the applicator during use.