Class II — International Medical Industries, Inc.
| Recalling firm | International Medical Industries, Inc. |
|---|---|
| Registered facility | INTL. MEDICAL INDUSTRIES (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Blister package had an unsealed edge compromising sterility. |
| 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. |
| Quantity | 228,000 DEVICES |
| Distribution | US Nationwide Distribution was made to AR, AZ, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, MD, MA, MI, MS, MO, MT, NE, NJ, NY, NC, OH, PA, SC, TX, and VA. There was no government/military/foreign distribution. |
| Initiated | 2022-09-16 |
| Classified | 2023-01-06 |
| Recall number | Z-0925-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — International Medical Industries, Inc. (Z-0925-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91276/
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