Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
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
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
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.