Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400 Recalled by International Medical Industries, Inc. Due to Blister package had an unsealed edge compromising sterility.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact International Medical Industries, Inc. directly.
Affected Products
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
Why Was This Recalled?
Blister package had an unsealed edge compromising sterility.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About International Medical Industries, Inc.
International Medical Industries, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report