# FDA recall Z-3002-2024

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2024-04-08.

## Product

Medline Convenience kits labeled as:   1) HEAD & NECK TRAY, Pack Number AM310B ;  2) HEAD & NECK CDS , Pack Number CDS780161K ;  3) HEAD & NECK CDS , Pack Number CDS780161L ;  4) HEAD & NECK PROCEDURE , Pack Number CDS780170R ;  5) HEAD & NECK PROCEDURE , Pack Number CDS780170S ;  6) CAROTID CDS-LF, Pack Number CDS840056N ;  7) CAROTID-LF, Pack Number CDS860039J ;  8) T & A PROCEDURE-LF, Pack Number CDS860047X ;  9) THORACOTOMY CDS , Pack Number CDS920065R ;  10) EAR CDS , Pack Number CDS980089L ;  11) EAR CDS , Pack Number CDS980089M ;  12) EAR CDS , Pack Number CDS980089N ;  13) EAR CDS , Pack Number CDS980089O ;  14) ENDOSCOPY , Pack Number CDS980201R ;  15) TYMPANOPLASTY , Pack Number CDS980203R ;  16) TYMPANOPLASTY , Pack Number CDS980203S ;  17) TYMPANO CDS , Pack Number CDS980374M ;  18) TYMPANO CDS , Pack Number CDS980374O ;  19) TYMPANO CDS , Pack Number CDS980374P ;  20) THORACOTOMY CDS , Pack Number CDS980446T ;  21) SINUS CDS , Pack Number CDS980579D ;  22) EENT-HEAD AND NE

## Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-3002-2024
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-08
- **Report date:** 2024-09-18

- **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-3002-2024

## Citation

> AI Analytics. FDA recall Z-3002-2024. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-3002-2024. Source: US FDA. Licensed CC0.

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