MEDLINE INDUSTRIES, LP - Northfield recalls Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PACK-LF SKU…

Recall date

April 22, 2025

Source

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

Recall number

Z-1811-2025

FDA classification

Class I

Brand / firm

MEDLINE INDUSTRIES, LP - Northfield

Sold / distributed

US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution.

Why it was recalled

Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PACK-LF SKU DYNJ44805M 3. CRANIOTOMY SKU CDS982719V CDS982719W DYNJ904168F DYNJ908404B DYNJ908723A DYNJ908723C 4. CRANIOTOMY #IMF 56646-LF SKU DYNJVB91001A 5. CRANIOTOMY CDS SKU CDS981888X CDS983467I 6. CRANIOTOMY PACK-LF SKU DYNJ09882G DYNJ09882I 7. CRANIOTOMY S NASSAU SKU DYNJ905879G 8. MHC CRANIOTOMY SKU DYNJ903713K DYNJ903713L 9. PAD CRANIOTOMY SKU DYNJ902149J