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FDA (Device enforcement)Recalled 2025-04-22class i

MEDLINE INDUSTRIES, LP - Northfield: Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C

Hazard

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

Details from the source

Reason for recall: Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate. Distribution: US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution. Quantity: 1853 total Lot/code info: UDI-DI 10888277858060 (EA); 40888277858061 (CASE) KIT LOTS 24CBJ925 24DBT405 24FBO318

UPC codes

10888277858060, 40888277858061

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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