Z-1251-2016 Class II Terminated
FDA device recall Z-1251-2016 was initiated by Amd Ritmed on February 24, 2016 and is designated Class II. Reason for recall: Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus. The recall status is terminated (terminated July 8, 2016). Affected quantity: 126 cases total (87 cases domestically and 39 cases internationally).
Recall Details
- Product Type
- Devices
- Report Date
- April 6, 2016
- Initiation Date
- February 24, 2016
- Termination Date
- July 8, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 126 cases total (87 cases domestically and 39 cases internationally)
Product Description
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
Reason for Recall
Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.
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.
Code Information
Lot 63927, expiration 2017-04