Medline Industries, LP: Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297C PACEMAKER PK DYNJT3454 PACEMAKE
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medline Industries, LP
- Product
- 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
- Reason / hazard
- Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution. OUS distribution pending.
- Recall initiated
- 2026-04-27
- Code info
- DYNJ61460C UDI-DI 10198459422133 lot 25KBA098 CDS840150Y UDI-DI 10198459303029 lots 25JBW220 26BBD028 DYNJ56297C UDI-DI 10198459513954 lot 25LMJ874 DYNJT3454 UDI-DI 10198459325663 lot 25KBG761 DYNJ33822L UDI-DI 10198459385582 lot 26AMA072 DYNJ900962O UDI-DI 10198459452581 lot 26CBC302 DYNJ54238L UDI-DI 10198459443114 lot 25LMH549 DYNJT6766 UDI-DI 10198459580888 lot 25KBM870 DYNJ909794C UDI-DI 10198459528002 lot 25LBF702 CVI5323A UDI-DI 10198459582035 lot 25KBM758 CDS983040M UDI-DI 10198459579813 lots 25KBO682 26BBB926
- Product quantity
- 49,654 kits total
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 98951
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