Recall Z-2302-2021
Delta Med SpA · initiated June 21, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122
Codes / lots: Lot 00A1160806
Reason for recall
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
FDA-determined cause: Process control
Action taken
The firm disseminated the notices on 06/21/2021 by email. The firm is requesting destruction of the affected devices at the consignee.
Details
- Recall number
- Z-2302-2021
- Initiated
- June 21, 2021
- Product code
- FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Quantity
- 1400 units
- Distribution
- US Nationwide distribution in the states of FL and MN.
- Recalling firm
- Delta Med SpA, Viadana
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2295-2021 Class II | DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272…Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2296-2021 Class II | DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF…Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2297-2021 Class II | DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b)…Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2298-2021 Class II | DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072…Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2299-2021 Class II | NEO DELTA Self Safe, I.V. Catheter REF 3738222Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2300-2021 Class II | NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 unitsProblems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2301-2021 Class II | NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2303-2021 Class II | NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2304-2021 Class II | NEO DELTA SELFSAFE PUR T, I.V. Catheter:Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2305-2021 Class II | WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475WProblems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |