Recall Z-0925-2023— International Medical Industries, Inc.

Name: FDA recall Z-0925-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-16

Class II · Ongoing

Class II FDA medical device recall by International Medical Industries, Inc., initiated 2022-09-16. It names one FDA 510(k) clearance: K173577. 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.. Reason: Blister package had an unsealed edge compromising sterility..

Recalling firm: International Medical Industries, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-09-16
Firm location: Pompano Beach, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K173577 — Guarded Luer ConnectorInternational Medical Industries, Inc.·cleared 2018-06-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Blister package had an unsealed edge compromising sterility.

Data sourced from openFDA. This site is unofficial and independent of the FDA.