FDA Recall
Open, Classified
DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072
Recall: Z-2298-2021
·
Initiated June 21, 2021
Recall
- Recall Number
- Z-2298-2021
- 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 Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072
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.