# FDA recall Z-2224-2024

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2024-03-14.

## Product

Sterile surgical convenience kits:    a.  Medline Cath Lab Special Procedure, Pack #00-RDF0360,  containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.    b.  Medline Angiography Pack, Pack #DYNJ26488W, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.    c.  Medline Heart Catheterization Pack, Pack #DYNJ30927Q, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000.    d.  Medline Heart Catheterization Pack, Pack #DYNJ30927R, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000.    e.  Medline Minor Special Procedure Pack, Pack #DYNJ38326G, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000.    f.  Medline Perm Cath Tray, Pack #DYNJ40423A, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorde

## Reason for recall

Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

## Distribution

US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.

## Key facts

- **Recall number:** Z-2224-2024
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-14
- **Report date:** 2024-07-10

- **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-2224-2024

## Citation

> AI Analytics. FDA recall Z-2224-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2224-2024. Source: US FDA. Licensed CC0.

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