Recall Z-1251-2016 ยท MHW Dressing, Compression
Amd Ritmed
IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile bandages), Single Use To cover and protect the primary dressing that is in contact with wounds from further injuries, contamination and infection. To be used in health care facilities
| Date | Feb 24, 2016 |
| Status | Terminated |
| Reason | Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus. |
| Root cause | Process control |
| Action | AMD Ritmed sent an Urgent - Medical Device Recall letter dated February 25, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are asked to examine all stocks immediately to determine if any of the affected product is on hand. If so, please discontinue distributing the product immediately and promptly return. If customers further distributed any of the product, please immediately contact your accounts advise them of the recall situation, and have them return their outstanding recalled stocks to you. R |
| Quantity | 126 cases total (87 cases domestically and 39 cases internationally) |
| Distribution | US Distribution including Puerto Rico and to the states of : DE, FL, KY, MI, NE and NJ., and Internationally to the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.