Medical device recalls Moderate risk

MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MAJOR VA…

Recall date
October 9, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0641-2025
FDA classification
Class II
Brand / firm
MEDLINE INDUSTRIES, LP - Northfield
Sold / distributed
US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MAJOR VAGINAL PACK-LF, REF DYNJ0826768P; 4) VAGINAL PACK, REF DYNJ59081C; 5)VAGINOPLASTY PACK, REF DYNJ65807C; 6) ACH MAJOR VAGINAL PACK, REF DYNJ67757B

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