Device product
DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
Z-2295-2021
Product summary
- Firm
- Delta Med SpA
- Event
- Event 88234
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 30,900 units
- Official record key
device-enforcement:Z-2295-2021
Official wording
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Code information: a) REF 3836272, Lot 11T80188 b) REF 3814272, Lot 11T80272 c) REF 3845272, Lot 12T80147 d) REF 3856272, Lot 12T80347
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