# FDA recall Z-0925-2023

> **International Medical Industries, Inc.** · Class II · device recall initiated 2022-09-16.

## 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 for recall

Blister package had an unsealed edge compromising sterility.

## 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.

## Key facts

- **Recall number:** Z-0925-2023
- **Recalling firm:** International Medical Industries, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-16
- **Report date:** 2023-01-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pompano Beach, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0925-2023

## Citation

> AI Analytics. FDA recall Z-0925-2023. Retrieved 2026-08-13 from https://api.ai-analytics.org/recall/Z-0925-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*