# FDA recall Z-0161-2025

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

## Product

Medline brand medical procedure convenience kits, labeled as:    1) CYSTO CDS, REF CDS983525D;   2) CYSTO CDS, REF CDS983525D;   3) CYSTO PACK-LF, REF DYNJ25834B;   4) CYSTO PACK, REF DYNJ35569C;   5) PAVILION MINOR PACK, REF DYNJ40724D;   6) CYSTOSCOPY PACK, REF DYNJ41105C;   7) MINOR PACK, REF DYNJ42132A;   8) RECTAL PRONE PACK, REF DYNJ43380A;   9) HERNIA APPENDECTOMY TEGH-LF, REF DYNJ46716;   10) CYSTO PACK, REF DYNJ47821F;   11) CYSTO PACK, REF DYNJ48978C;   12) CYSTO PACK, REF DYNJ50428C;   13) MID HUDSON CYSTO PACK, REF DYNJ53418B;   14) CYSTO PACK-LF, REF DYNJ55479D;   15) CYSTO PACK, REF DYNJ58445A;   16) MINOR PACK, REF DYNJ58566B;   17) CSTM PK GEN NEW ENGL SURG, REF DYNJ59431;   18) RIDGEWOOD LAP PACK-LF, REF DYNJ60077A;   19) FLEXIBLE CYS PACK, REF DYNJ62111C;   20) CYSTO PACK, REF DYNJ65830A;   21) MAIN & ODS CYSTO PACK, REF DYNJ66821A;   22) PROCEDURE CYSTO PACK, REF DYNJ68883;   23) CYSTO PACK, REF DYNJ69729;   24) MINOR SURGERY PACK, REF DYNJ80004;   25) LAPAROSCOPY PA

## 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-0161-2025
- **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-0161-2025

## Citation

> AI Analytics. FDA recall Z-0161-2025. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-0161-2025. Source: US FDA. Licensed CC0.

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