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U.S. Department of Health and Human Services

Class 2 Device Recall PrepFill Guarded Luer Connector (GLC)

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  Class 2 Device Recall PrepFill Guarded Luer Connector (GLC) see related information
Date Initiated by Firm September 16, 2022
Date Posted January 07, 2023
Recall Status1 Open3, Classified
Recall Number Z-0925-2023
Recall Event ID 91276
510(K)Number K173577  
Product Classification Set, i.V. Fluid transfer - Product Code LHI
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.
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.
Recalling Firm/
Manufacturer		 International Medical Industries, Inc.
2981 Gateway Dr
Pompano Beach FL 33069-4326
For Additional Information Contact
954-917-9570 Ext. 222
Manufacturer Reason
for Recall		 Blister package had an unsealed edge compromising sterility.
FDA Determined
Cause 2		 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 not use the lots and have all identified product to be returned. Notify your customers and if your customers are not end users (such as another medical device distributor or supply company) they must notify their customers to the end user level. Please identify the number of devices by lot, complete the table on page two, return this completed form via email to Sfoott.@imiweb.com . Actions to be taken by Kitters/Re-packagers: Do not use the lots and have all identified product to be returned. Please identify the number of devices by lot, return this completed form via email. IMI will contact you to arrange for return or destruction of the product. Shipping/reconciliation Method Information: IMI's preferred method to address affected inventory is to return the product directly to IMI regardless of business or customer affiliation to IMI. After receiving a report on a second lot, the firm expanded the recall to include all unexpired lots. A recall letter was issued on 11/17/2022 via email and was similar to the initial recall letter except that it included additional part numbers and lot numbers. If you have any questions, call IMI, Inc. at 954-917-9570 ext222.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LHI and Original Applicant = International Medical Industries Inc.
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