# FDA recall Z-2228-2024

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

## Product

Sterile convenience kits:    a.  Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing component Sterile Curved Kelly Hemostat, Reorder #66175.    b.  Medline Cath Lab Pack, Pack #DYNJ56141A, containing a Pure Pouch containing component Medline DYND0400 O.R. Scissors, S/B, 5.5 Sterile.    c.  Medline Sterile Loop Insertion Tray, Pack DYNJ62843A, containing a Pure Pouch containing Medline Reorder #DYNJ04048, Kelly Forceps/Std Str Sterile.    d.  Medline Radiology Minor MVH, Pack #DYNJ63555C, containing a Pure Pouch containing component Sterile Curved Kelly Hemostat, Reorder #66175.    e.  Medline Basic Pack, Pack #DYNJ80649B, containing a Pure Pouch containing component Medline DYND0400 O.R. Scissors, S/B, 5.5 Sterile.

## 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-2228-2024
- **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-2228-2024

## Citation

> AI Analytics. FDA recall Z-2228-2024. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-2228-2024. Source: US FDA. Licensed CC0.

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