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International Medical Industries, Inc. recalls Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, St
Recalled January 18, 2023 · FDA recall Z-0925-2023 · International Medical Industries
Hazard
Blister package had an unsealed edge compromising sterility. · FDA Class II
Units
228,000 DEVICES
Sold at
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.
Description
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.
Manufacturer(s)
International Medical Industries, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →