Device product
CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K
Z-1079-2021
Product summary
- Event
- Event 87145
- Status
- Terminated
- Classification
- Class II
- Quantity
- 137,346 kits
- Official record key
device-enforcement:Z-1079-2021
Official wording
Reason: Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
Code information: Lot: 911609X
Distribution pattern: Global Distribution. US Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
foreign material