FDA Recall
Open, Classified
NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
Recall: Z-2301-2021
·
Initiated June 21, 2021
Recall
- Recall Number
- Z-2301-2021
- 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
NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
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
20,000 units