# FDA recall Z-0156-2025

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

## Product

Medline brand, medical procedure convenience kits, labeled as:    a) CUH OPEN HEART A B C - CDS, REF CDS983202I;   a) PICC INSERTION KIT, REF DYNDC2486A;   a) OPEN HEART PACK, REF DYNJ01201L;   a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G;   a) COTTON ROLL KIT-LF, REF DYNJ32727A;   a) VASCULAR PACK-LF, REF DYNJ32915B;   a) SUAREZ AVR/MVR PACK, REF DYNJ35884C;   a) VALVE ACCESSORY PACK, REF DYNJ36241K;   a) ENSEMBLE ABDO-PERINEAL-LF, REF DYNJ38084B;   a) EP PACK, REF DYNJ40488;   a) PACEMAKER PACK SMGH-LF, REF DYNJ41925G;   a) PACEMAKER TEGH-LF, REF DYNJ46745A;   a) VEIN AND LASER PACK, REF DYNJ49874;   a) DR NACKMAN VEIN PACK, REF DYNJ56235;   a) NEUROVASCULAR PACK, REF DYNJ66718A;   a) VEIN TRAY, REF DYNJ69012C;   a) LOOP RECORDER-LF, REF DYNJ69196;   a) U BAR DRAPE, REF DYNJ80064;   a) ENDO, REF DYNJ903814B;   a) CARDIAC PROCEDURE, REF DYNJ908126;   a) CARDIAC PROCEDURE, REF DYNJ908126;   a) VASCULAR EXTREMITY PACK, REF SYNJ10322A;   a) VASCULAR EXTREMITY, REF SYNJ910026A

## 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-0156-2025
- **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-0156-2025

## Citation

> AI Analytics. FDA recall Z-0156-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0156-2025. Source: US FDA. Licensed CC0.

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