CLASS II ONGOING Device recall · Reported 18 Jan 2023 · FDA Enforcement Report

Prep-Fill Guarded Luer Connector (GLC) recalled by International Medical

International Medical Industries is recalling Prep-Fill Guarded Luer Connector (GLC): a, distributed nationwide in the US. The recall was initiated on 16 Sep 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa. 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.

Quantity recalled228,000 DEVICES

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0925-2023
FDA event ID: 91276
Recalling firm: International Medical Industries, Pompano Beach, FL
Classification: Class II
Status: Ongoing
Recall initiated: 16 Sep 2022
FDA classified: 6 Jan 2023
Reported: 18 Jan 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Other Medical Devices

Timeline

16 Sep 2022	Recall initiated by company
6 Jan 2023	Classified by FDA	+112 days
18 Jan 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Blister package had an unsealed edge compromising sterility.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Arkansas Arizona California Colorado Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Massachusetts Maryland Michigan Missouri Mississippi Montana North Carolina Nebraska

Questions about this recall

Why was it recalled?

Blister package had an unsealed edge compromising sterility.

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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