Z-0925-2023 Class II Ongoing
FDA device recall Z-0925-2023 was initiated by International Medical Industries, Inc. on September 16, 2022 and is designated Class II. Reason for recall: Blister package had an unsealed edge compromising sterility. The recall status is ongoing. Affected quantity: 228,000 DEVICES.
Recall Details
- Product Type
- Devices
- Report Date
- January 18, 2023
- Initiation Date
- September 16, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 228,000 DEVICES
Product Description
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.
Distribution Pattern
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.
Code Information
a. Part 57-400 - Lot numbers 45266, 44549, 44120, 43800, 43626, 42634, 42236, 39350, 37176, 36596, 33074. UDI: B212574001. b. Part 57-400W - Lot numbers 39371, 37093, 37086, 37079, 39378, 39364, 39357, 36558. UDI: B21257400W1. c. Part 57-401 - Lot numbers 45047, 43633. UDI: B212574011. d. Part 57-402 - Lot number 37151. UDI: B212574021.