Official recall notice

FDA DeviceClass IINotable

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

Recall date
2026-06-24
FDA class
Class II

Why it was recalled

Hazard

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

Recommended action

What to do

49,654 kits total

Product description

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

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