Prep-Fill Guarded Luer Connector — Class II medical device recall Z-0925-2023
Ongoing recall by International Medical Industries, Inc., reported 2023-01-18, distributed nationwide. Blister package had an unsealed edge compromising sterility.
| Recall number | Z-0925-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | International Medical Industries, Inc., Pompano Beach, FL, United States |
| Recall initiated | 2022-09-16 |
| Classified | 2023-01-06 |
| Reported by FDA | 2023-01-18 |
| Distributed | Nationwide (US) |
| Quantity | 228,000 devices |
| Reason classes | sterility |
| Lot numbers | 33074, 36558, 36596, 37079, 37086, 37093, 37151, 37176, 39350, 39357, 39364, 39371, 39378, 42236, 42634, 43626, 43633, 43800, 44120, 44549, 45047, 45266 |
| Model numbers | 57-400, 57-400W, 57-401, 57-402, 57-403 |
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 for recall
Blister package had an unsealed edge compromising sterility.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0925-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.