FDA Device recall Z-0925-2023
Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile
- FDA Device
- Class II
- ongoing
- Published 2023-01-18
On 2023-01-18 the FDA classified a Class II recall of Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile by International Medical Industries, citing blister package had an unsealed edge compromising sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0925-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-16 |
| Published | 2023-01-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | International Medical Industries |
| Distribution | US |
Product
Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile; b. Part number 57-400W, Female Lock - Female Lock Guarded Luer Connector, Sterile; c. Part number 57-401, Female Lock - Male Lock Guarded Luer Connector, Sterile; d. Part number 57-402, Female Slip - Female Lock Guarded Luer Connector, Sterile; and e. Part number 57-403, Female Slip - Female Slip Guarded Luer Connector.
Reason
Blister package had an unsealed edge compromising sterility.
Identifiers
| code_info | a. Part 57-400 - Lot numbers 45266, 44549, 44120, 43800, 43626, 42634, 42236, 39350, 37176, 36596, 33074. UDI: B21257…a. Part 57-400 - Lot numbers 45266, 44549, 44120, 43800, 43626, 42634, 42236, 39350, 37176, 36596, 33074. UDI: B212574001. b. Part 57-400W - Lot numbers 39371, 37093, 37086, 37079, 39378, 39364, 39357, 36558. UDI: B21257400W1. c. Part 57-401 - Lot numbers 45047, 43633. UDI: B212574011. d. Part 57-402 - Lot number 37151. UDI: B212574021. |
|---|
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-0925-2023%22
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