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
FDA Recall Z-1251-2016 · Posted None
Recalling FirmAmd Ritmed
Recall StatusTerminated
Product CodeMHW
Date Initiated2016-02-24
Date Terminated2016-07-08
Product Quantity126 cases total (87 cases domestically and 39 cases internationally)
Reason for Recall
Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.
Firm 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. Return these stocks as indicated above. Please return the enclosed response form immediately providing the requested information by fax 1-866-871-3455 or by email: [email protected].
Customers with questions can call 1-800-445-0340 or email AMD Customer Service: [email protected].
Root Cause
Process control
Distribution Pattern
US Distribution including Puerto Rico and to the states of : DE, FL, KY, MI, NE and NJ., and Internationally to the country of Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.