# FDA recall Z-1069-2023

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2022-11-17.

## Product

Sterile Procedural Trays, labeled as the following:    a.	BREAST BIOPSY PACK-LF  b.	BREAST BIOPSY PACK  c.	LAPAROTOMY PACK  d.	BREAST PACK  e.	SOFT TISSUE PACK  f.	HEMORRHOID PACK  g.	RECTAL  h.	BREAST  i.	BREAST

## Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

## Key facts

- **Recall number:** Z-1069-2023
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-17
- **Report date:** 2023-02-15

- **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-1069-2023

## Citation

> AI Analytics. FDA recall Z-1069-2023. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-1069-2023. Source: US FDA. Licensed CC0.

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