Medline brand recalled over sterility concerns

Recall date

September 4, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

MEDLINE INDUSTRIES, LP - Northfield recalls Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC I…

Recall number

Z-0156-2025

FDA classification

Class II

Brand / firm

MEDLINE INDUSTRIES, LP - Northfield

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Why it was recalled

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

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 brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT, REF DYNDC2486A; a) OPEN HEART PACK, REF DYNJ01201L; a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G; a) COTTON ROLL KIT-LF, REF DYNJ32727A; a) VASCULAR PACK-LF, REF DYNJ32915B; a) SUAREZ AVR/MVR PACK, REF DYNJ35884C; a) VALVE ACCESSORY PACK, REF DYNJ36241K; a) ENSEMBLE ABDO-PERINEAL-LF, REF DYNJ38084B; a) EP PACK, REF DYNJ40488; a) PACEMAKER PACK SMGH-LF, REF DYNJ41925G; a) PACEMAKER TEGH-LF, REF DYNJ46745A; a) VEIN AND LASER PACK, REF DYNJ49874; a) DR NACKMAN VEIN PACK, REF DYNJ56235; a) NEUROVASCULAR PACK, REF DYNJ66718A; a) VEIN TRAY, REF DYNJ69012C; a) LOOP RECORDER-LF, REF DYNJ69196; a) U BAR DRAPE, REF DYNJ80064; a) ENDO, REF DYNJ903814B; a) CARDIAC PROCEDURE, REF DYNJ908126; a) CARDIAC PROCEDURE, REF DYNJ908126; a) VASCULAR EXTREMITY PACK, REF SYNJ10322A; a) VASCULAR EXTREMITY, REF SYNJ910026A