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Open, Classified

Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297C PACEMAKER PK DYNJT3454 PACEMAKER/ICD PACK DYNJ33822L PAD OPEN HEART DYNJ900962O PEDIATRIC OPEN HEART DYNJ54238L DYNJT6766 STAZ BASIC VASCULAR DYNJ909794C VASCULAR ACCESS KIT CVI5323A VASCULAR CDS CDS983040M

FDA Recall Z-2418-2026 · Posted 2026-06-12

Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeOEZ
Date Initiated2026-04-27
Product Quantity49,654 kits total

Reason for Recall

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

Firm Action

Firm began notifying consignees on 4/27/2026. Customers were instructed to request stickers to over-label affected convenience kits with a warning label. Warning label indicates for user to remove the affected component and replace it with product from supply. No kits are to be returned.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution. OUS distribution pending.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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