IMCO Conforming Stretch Gauze Bandages Recalled for Sterility Failure
Amd Ritmed is recalling IMCO Conforming Stretch Gauze Bandages because FDA testing found the product was not sterile and tested positive for Bacillus bacteria.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that failed sterility requirements and tested positive for Bacillus bacteria, posing a risk of wound infection. This aligns with the rubric for high-risk pathogens or risk-of-harm products where injury has not yet been reported.
Plain-English summary
Amd Ritmed is recalling IMCO brand Conforming Stretch Gauze Bandages (4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC) because the product does not meet sterility requirements. FDA analysis confirmed that the bandages tested positive for Bacillus bacteria.
The recall affects Lot 63927, which has an expiration date of 2017-04. A total of 126 cases were distributed, with 87 cases distributed domestically in the United States (including Puerto Rico and the states of DE, FL, KY, MI, NE, and NJ) and 39 cases distributed internationally to Canada. The product is intended for single use in health care facilities to cover and protect primary dressings in contact with wounds.
Health care facilities and consumers should stop using the affected bandages immediately. Users should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the supplier or disposed of according to local regulations to prevent potential infection or contamination of wounds.
The recalled product
- 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…
- Manufacturer
- Amd Ritmed
- Category
- Medical Device — Wound Care
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 63927
- expiration 2017-04
Distribution
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