Device product
IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.
Z-2112-2014
Product summary
- Event
- Event 68556
- Status
- Terminated
- Classification
- Class I
- Quantity
- 3,135 cartons of 4/10g tubes
- Official record key
device-enforcement:Z-2112-2014
Official wording
Reason: Potential for microbial contamination of the product.
Code information: Lot #3P3446
Distribution pattern: Worldwide Distribution -- USA, including the states of Alabama, Arkansas, Georgia, Illinois, Kentucky, Louisiana, Missouri, Mississippi, New Jersey, South Carolina, Tennessee, Texas, and Virginia; and the country of Canada.
Derived failure modes
-
Microbial contamination
microbial contamination