# FDA recall Z-0164-2025

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2024-09-04.

## Product

Medline brand medical procedure convenience kits, labeled as:    a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S;   b) TRAY FOL LATX UM COUD 16FR  MF, REF DYND150216CS;   c) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S;   d) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S;   e) TRAY FOL LATX UM COUD 18FR  MF, REF DYND150218CS;   f) TRAY FOLEY LTX 18FR 10ML UM MF, REF DYND150218S;   g) TRAY FOLEY LTX 18FR 10ML UM MF, REF DYND150218S;   h) TRAY FOLEY SIL 16FR 10ML W/UM, REF DYND150816;   i) TRAY FOL SIL UM COUD 16FR MF, REF DYND150816CS;   j) TRAY FOL SIL 16FR 10ML W/UM MF, REF DYND150816S;   k) TRAY FOL SIL UM COUD 18FR MF, REF DYND150818CS;   l) TRAY FOL SIL 18FR 10ML W/UM MF, REF DYND150818S

## Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

## Key facts

- **Recall number:** Z-0164-2025
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-04
- **Report date:** 2024-10-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0164-2025

## Citation

> AI Analytics. FDA recall Z-0164-2025. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-0164-2025. Source: US FDA. Licensed CC0.

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