FDA DeviceClass IINotable

FDA Recall: Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297

Date: 2026-06-24
Brand: Medline Industries, LP
Category: Medical Device
FDA Class: Class II

Description

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

Hazard

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

Remedy

49,654 kits total

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