Device product
DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572
Z-2296-2021
Product summary
- Firm
- Delta Med SpA
- Event
- Event 88234
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 203,680 units
- Official record key
device-enforcement:Z-2296-2021
Official wording
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Code information: a) REF 3832572: Lot 11T80189 b) REF 3842572, Lot 11T80198 c) REF 3821572, Lot 11T80149 d) REF 3833572, Lot 11T80292 e) REF 3831572, Lot 12T80230 f) REF 3810572, Lot 12T80302 g) REF 3852572, Lot 12T80349
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