Reported Jan 18, 2023 · Ongoing
Prep-Fill Guarded Luer Connector (GLC)
International Medical Industries, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: International Medical Industries, Inc. · 2981 Gateway Dr · Pompano Beach, FL · 33069-4326
Is this the product you have?
Prep-Fill Guarded Luer Connector (GLC)
5 of 5 products
| Model / number | Product as published |
|---|---|
57-400 | Female Lock - Female Lock Guarded Luer Connector, Sterile |
57-400W | Female Lock - Female Lock Guarded Luer Connector, Sterile |
57-401 | Female Lock - Male Lock Guarded Luer Connector, Sterile |
57-402 | Female Slip - Female Lock Guarded Luer Connector, Sterile; and |
57-403 | Female Slip - Female Slip Guarded Luer Connector. |
- Amount recalled
- 228,000 DEVICES
Where it was sold
Why it was recalled
Blister package had an unsealed edge compromising sterility.
This product could cause temporary or reversible health problems — stop using it.
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