Recall record at a glance
| Official record | Z-1251-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Amd Ritmed |
| Report date | Apr 6, 2016 |
| Recall initiation date | Feb 24, 2016 |
| Quantity | 126 cases total (87 cases domestically and 39 cases internationally) |
| Location | Lachine, N/A, Canada |
Official 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
Why the product was recalled
Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.
Distribution information
US Distribution including Puerto Rico and to the states of : DE, FL, KY, MI, NE and NJ., and Internationally to the country of Canada.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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