# FDA recall Z-1067-2023

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

## Product

Sterile Procedural Trays, labeled as the following:  a.	EP LAB PACEMAKER PACK b.	OPEN HEART CDS c.	OPEN HEART CDS d.	AAA CDS e.	OPEN HEART CDS f.	PACEMAKER CDS g.	HEART CDS h.	VALVE PACK i.	OPEN HEART CDS-3 j.	OPEN HEART PACK k.	OPEN HEART PACK l.	OPEN HEART ADULT m.	OPEN HEART CDS PART A n.	GLENNON OPEN HEART CDS o.	OPEN HEART CDS p.	MEMORIAL MED CTR BYPASS q.	OPEN HEART PEDS r.	OPEN HEART CDS-4 s.	OPEN HEART t.	CAB CDS u.	VASCULAR CDS v.	VALVE CDS w.	OPEN HEART PACK-LF x.	VASCULAR CDS-LF y.	OPEN HEART B CDS-LF z.	CRANIOTOMY CDS aa.	OPEN UROLOGY CDS-LF bb.	TOTAL KNEE CDS cc.	LOWER EXTREMITY CDS-LF dd.	LAMINECTOMY CDS ee.	ENDOVASCULAR CDS ff.	VASCULAR gg.	VASCULAR CDS-3 hh.	VASCULAR ACCESS CDS ii.	ZALE PUMP CDS jj.	CUH ENDOVASCULAR CDS kk.	CUH MINOR VASCULAR CDS ll.	FHT CVOR CABG mm.	OPEN HEART CDS nn.	OPEN HEART CDS oo.	CAROTID ENDARTERECTOMY CDS-LF pp.	PACER CDS qq.	PERIPHERAL VASCULAR CDS rr.	ACH OPEN HEART ss.	ACH OPEN HEART tt.	OPEN HEART CDS uu.	VASCULAR CDS vv.	CV CDS ww.	OPEN H

## 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-1067-2023
- **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-1067-2023

## Citation

> AI Analytics. FDA recall Z-1067-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1067-2023. Source: US FDA. Licensed CC0.

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