Device product
MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE
Z-1217-2022
Product summary
- Event
- Event 90125
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 500 boxes of 100 units
- Official record key
device-enforcement:Z-1217-2022
Official wording
Reason: Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
Code information: DI: (01) 40888277367358; All Envirolite lot numbers which have the following format on individual packaging: YYMMDD X where YY is last 2 digits of Year of production, MM is the number of the month of production, DD is the day of production and X is the leading number of the raw material batch number.
Distribution pattern: US and Panama
Derived failure modes
-
Microbial contamination
microbial contamination