Z-2296-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 25, 2021
- Initiation Date
- June 21, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 203,680 units
Product Description
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
Reason for Recall
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Distribution Pattern
US Nationwide distribution in the states of FL and MN.
Code Information
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