Device 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
Z-1251-2016
Product summary
- Firm
- Amd Ritmed
- Event
- Event 73324
- Status
- Terminated
- Classification
- Class II
- Quantity
- 126 cases total (87 cases domestically and 39 cases internationally)
- Official record key
device-enforcement:Z-1251-2016
Official wording
Reason: Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.
Code information: Lot 63927, expiration 2017-04
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.
Derived failure modes
-
Unknown
Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.