FDA Recall
Open, Classified
DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
Recall: Z-2295-2021
·
Initiated June 21, 2021
Recall
- Recall Number
- Z-2295-2021
- Event Number
- 88234
- Firm
- Delta Med SpA Via Guido Rossa 20 Viadana Italy
- FEI Number
- 3006846316
- Product Code
- FOZ
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- June 21, 2021
Description
DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
Reason
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Action
The firm disseminated the notices on 06/21/2021 by email. The firm is requesting destruction of the affected devices at the consignee.
Distribution
US Nationwide distribution in the states of FL and MN.
Quantity
30,900 units