FDA Device recall Z-0166-2023
MEDLINE CVC BARRIER KIT, REF DYNJ80485
- FDA Device
- Class II
- ongoing
- Published 2022-11-09
On 2022-11-09 the FDA classified a Class II recall of MEDLINE CVC BARRIER KIT, REF DYNJ80485 by Medline Industries Northfield, citing medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0166-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-30 |
| Published | 2022-11-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
MEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical procedures.
Reason
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Identifiers
| code_info | UDI/DI (01) 40195327045471, Lot Number 22ABT774 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0166-2023%22
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