# FDA recall Z-1079-2023

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

## Product

Sterile Procedural Trays, labeled as the following:   a.	BASIN SET-UP PACK b.	LAP CHOLE CDS c.	MAJOR CDS d.	UROLOGY MINOR CDS e.	UROLOGY MAJOR CDS f.	SINGLE BASIC CDS g.	ORGAN RECOVERY CDS h.	GENERAL ABD CDS i.	BURN CDS j.	MINOR k.	MAJOR VASCULAR l.	BASIC CORE CDS m.	ROBOTIC PROCEDURE n.	MAJOR VASCULAR CDS o.	PEDI LITHOTOMY p.	MAJOR CDS-1 q.	MINOR CDS-1 r.	VASCULAR CDS-4 s.	SEPTOPLASTY CDS t.	DENTAL CDS u.	MINOR GENERAL  CDS v.	CUH UROLOGY LITHOTOMY CDS w.	CUH UROLOGY OPEN CDS x.	CUH LIVER TRANSPLANT CDS y.	THORACOTOMY CDS z.	XI THORACIC ROBOTIC CDS aa.	GENERAL CDS bb.	THORACIC CDS cc.	MINOR PROCEDURE dd.	EXTREMITY CDS ee.	DOUBLE BASIN CDS ff.	PEDIATRIC gg.	P.V.STARTER TRAY hh.	CV PACK ii.	MINOR GENERAL-LF jj.	VASCULAR PACK-LF kk.	UROLOGY PACK ll.	MINOR LINEN PACK-LF mm.	ABDOMINAL PACK-LF nn.	MINOR SURGICAL SETUP PACK-LF oo.	MINOR GENERAL PACK-LF pp.	MAJOR ABDOMINAL PACK-LF qq.	MINOR VASCULAR PACK-LF rr.	MAJOR BASIN PACK-LF ss.	DAVINCI PACK-LF tt.	MINOR ENT HARPER PACK-LF uu.	CHOM STAR

## 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-1079-2023
- **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-1079-2023

## Citation

> AI Analytics. FDA recall Z-1079-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1079-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*