Device product
NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
Z-2300-2021
Product summary
- Firm
- Delta Med SpA
- Event
- Event 88234
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5000 units
- Official record key
device-enforcement:Z-2300-2021
Official wording
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Code information: REF 3708122, Lot 00A1160627
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