Z-0925-2023Class II

Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer...

Name: Z-0925-2023 Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer...
Creator: International Medical Industries, Inc.
Published: 2022-09-16
License: https://open.fda.gov/license/

Intl. Medical Industries / initiated 2022-09-16 / Open, Classified / root cause: manufacturing process

FDA source

International Medical Industries, Inc. began a recall of 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 -... on 2022-09-16. FDA classified it as Class II and gives the reason as "Blister package had an unsealed edge compromising sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0925-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-16
Posted: 2023-01-07
Recalling firm: Intl. Medical Industries
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.
Product code: LHI Set, I.V. Fluid Transfer
Reason for recall: Blister package had an unsealed edge compromising sterility.
Root cause tag: manufacturing process
FDA 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 [email protected] . 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 [email protected] . 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0925-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0925-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-06

Product code LHI

K173577Class IIGuarded Luer ConnectorInternational Medical Industries, Inc. / cleared 2018-06-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)