# FDA recall Z-2227-2024

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

## Product

Sterile convenience kit:    Medline Birthing Room Pack, Pack #DYNJ38429D, containing a Pure Pouch component Sterile Sharp/Blunt Scissors 5.5", Reorder #65945 and containing a Pure Pouch component Sterile 5.5" Episiotomy Scissors, Reorder #67645.

## 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-2227-2024
- **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-2227-2024

## Citation

> AI Analytics. FDA recall Z-2227-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2227-2024. Source: US FDA. Licensed CC0.

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