# FDA recall Z-1078-2023

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

## Product

Sterile Procedural Trays, labeled as the following:     a.	ST. ANNE'S MAJOR BASIN SET UP  b.	SINGLE BASIN SET  c.	DOUBLE BASIN SET  d.	LAPAROTOMY BASIN  e.	ORTHOPEDIC CUSTOM BASIN SET  f.	OISC BASIN TRAY  g.	BASIN PACK  h.	BASIN SET  i.	SURGI START PACK  j.	PK, GEN-SET UP - MIDWEST  k.	SINGLE BASIN PACK-LF  l.	AGHM MINOR SINGLE PACK  m.	MINOR PACK  n.	SINGLE BASIN PACK  o.	MAJOR BASIN PACK  p.	BASIC SET UP-LF  q.	BASIC SET-UP-LF  r.	BASIN PACK  s.	MINOR BASIN  t.	AMC MAJOR BASIN  u.	AMC MAJOR BASIN

## 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-1078-2023
- **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-1078-2023

## Citation

> AI Analytics. FDA recall Z-1078-2023. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1078-2023. Source: US FDA. Licensed CC0.

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