Device product
WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
Z-2305-2021
Product summary
- Firm
- Delta Med SpA
- Event
- Event 88234
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 40,000 units
- Official record key
device-enforcement:Z-2305-2021
Official wording
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Code information: a) REF PIVD2010W, Lot 1100256 b) REF PIV2210W, Lot 1100316 c) REF PIV2475W, Lot 1200084
Distribution pattern: US Nationwide distribution in the states of FL and MN.
Derived failure modes
-
Unknown
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device