DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572
- Recall Initiated
- June 21, 2021
- Recall Number
- Z-2296-2021
- Quantity
- 203,680 units
Reason for Recall
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Distribution
US Nationwide distribution in the states of FL and MN.
Lot / Code Info
a) REF 3832572: Lot 11T80189 b) REF 3842572, Lot 11T80198 c) REF 3821572, Lot 11T80149 d) REF 3833572, Lot 11T80292 e) REF 3831572, Lot 12T80230 f) REF 3810572, Lot 12T80302 g) REF 3852572, Lot 12T80349
Root 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.
More recalls by Delta Med Spa Via Guido Rossa 20 Viadana Italy
NEO DELTA SELFSAFE PUR T, I.V. Catheter:
Jun 21, 2021
NEO DELTA Self Safe T, I.V. catheter of PUR
a) REF 3779422
b) REF 3769522
c) REF 3708522
Jun 21, 2021