Recall Z-0925-2023 ยท LHI Set, I.V. Fluid Transfer
International Medical Industries, Inc.
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-
| Date | Jan 7, 2023 (initiated Sep 16, 2022) |
| Status | Open, Classified |
| Reason | Blister package had an unsealed edge compromising sterility. |
| Root cause | Process control |
| Action | The recalling firm issued undated "URGENT: MEDICAL DEVICE RECALL" letters via email on 9/16/2022 informing the consignee of the reason for recall, risk to health, and actions to be taken by the customer/user, which included the following: Actions to be taken by the Customer/User: Do not use the lots and have all identified product be returned. Please identify the number of devices by lot, complete the table on page two, return this completed form via email to Sfoott@imiweb.com . IMI will contact you to arrange for return or destruction of the product. Actions to be taken by Distributors: Do |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173577 | Guarded Luer Connector International Medical Industries, Inc., Jun 7, 2018 |