Recall Z-1251-2016— Amd Ritmed
Class II · Terminated
Class II FDA medical device recall by Amd Ritmed, initiated 2016-02-24, terminated 2016-07-08. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus..
- Recalling firm
- Amd Ritmed
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-24
- Terminated
- 2016-07-08
- Firm location
- Lachine, N/A, Canada
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.