Device product
NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
Z-2301-2021
Product summary
- Firm
- Delta Med SpA
- Event
- Event 88234
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20,000 units
- Official record key
device-enforcement:Z-2301-2021
Official wording
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Code information: a) REF 3779422, Lot 00A1160635 b) REF 3769522, Lot 00A1160656 c) REF 3708522, Lot 00A1160638
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