# FDA recall Z-0160-2025

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

## Product

Medline brand medical procedure convenience kits, labeled as:    1) T&A CDS-LF, REF CDS982091I;   2) TONSIL CDS, REF CDS984492B;   3) RV T&A PACK-LF, REF DYNJ0798129I;   4) DIRECT MICRO LARYNG PK-LF, REF DYNJ30591I;   5) APU LINE PACK, REF DYNJ37171A;   6) T&A PACK-LF, REF DYNJ40836F;   7) ENT PACK, REF DYNJ44249J;   8) TONSIL PACK, REF DYNJ44349L;   9) TONSIL PACK, REF DYNJ44349M;   10) NASAL PACK, REF DYNJ53200C;   11) TONSIL & ADENOIDS PACK, REF DYNJ53270C;   12) FTMC MYRINGOTOMY PACK-LF, REF DYNJ54610A;   13) HEAD AND NECK PACK, REF DYNJ55255C;   14) ENT T&A PACK, REF DYNJ58979;   15) EENT PACK, REF DYNJ62927;   16) ENT, REF DYNJ63190A;   17) D L B PACK, REF DYNJ66274A;   18) ASC T&A, REF DYNJ67109B;   19) TONSIL T AND A PACK SHD, REF DYNJ68417C;   20) T A PACK, REF DYNJ80227B;   21) TONSIL AND ADENOID PACK, REF DYNJ80559A;   22) T AND A PACK UMMC KIT, REF DYNJ81880;   23) T/A ENDO PACK, REF DYNJ83158;   24) JVL - MODULE T A  PK, REF DYNJ84083;   25) T&A, REF DYNJ900289J;   26) T&A

## 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-0160-2025
- **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-0160-2025

## Citation

> AI Analytics. FDA recall Z-0160-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0160-2025. Source: US FDA. Licensed CC0.

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