# FDA recall Z-0625-2025

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2024-10-09.

## Product

MEDLINE convenience kits labeled as:   1) MAJOR VASCULAR-LF, REF CDS840232L;  2) AVF-LF, REF CDS840233I;  3) GENERAL AAA #11-RF, REF CDS840261AB;  4) HEART CDS, REF CDS840387T;  5) OPEN HEART CDS PART A, REF CDS840402AF;  6) OPEN HEART CDS PART A, REF CDS840402AI;  7) HEART PACK, REF CDS840459R;  8) CAROTID-LF, REF CDS860039K;  9) CAROTID-LF, REF CDS860039L;  10) OPEN HEART ADULT KIT, REF CDS981319AD;  11) BAPTIST AAA, REF CDS982400M;  12) ZALE PUMP CDS, REF CDS983187G;  13) PEDIATRIC CARDIAC CDS-LF, REF CDS983481G;  14) MAJOR VASCULAR, REF CDS983489K;  15) CAROTID, REF CDS983495N;  16) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I;  17) AV FISTULA, REF CDS983638K;  18) PERIPHERAL VASCULAR CDS, REF CDS983723I;  19) ACH OPEN HEART, REF CDS983773J;  20) VASCULAR, REF CDS984255K;  21) VASCULAR CDS, REF CDS984275I;  22) OPEN HEART CDS, REF CDS984276O;  23) OPEN HEART CDS, REF CDS984355G;  24) OPEN HEART CDS, REF CDS984355I;  25) SMH VASCULAR CDS, REF CDS984584M;  26) VASCULAR CDS-LF, REF C

## Reason for recall

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0625-2025
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-09
- **Report date:** 2024-12-11

- **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-0625-2025

## Citation

> AI Analytics. FDA recall Z-0625-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0625-2025. Source: US FDA. Licensed CC0.

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