FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1251-2016
- Recalling firm
- Amd Ritmed
- Product
- 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
- Status
- Terminated
- Initiated
- 2016-02-24
- Posted
- not on file
- Terminated
- 2016-07-08
- 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. 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: AMDCustomerservice@amdritmed.com. Customers with questions can call 1-800-445-0340 or email AMD Customer Service: AMDCustomerservice@amdritmed.com.
- 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.
- Lot, serial or model codes
- Lot 63927, expiration 2017-04
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MHW
- Firm FEI
- 3002861073
- Firm city
- Lachine
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28