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 57-403, Female Slip - Female Slip Guarded Luer Connector.

Recall number

Z-0925-2023

Recalling firm

International Medical Industries, Inc.

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.

Status

Open, Classified

Initiated

2022-09-16

Posted

2023-01-07

Terminated

not on file

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 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

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.

Lot, serial or model codes

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.

510(k) numbers

["K173577"]

PMA numbers

not on file

Product code

LHI

Firm FEI

1217831

Firm city

Pompano Beach

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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