Device product
Medline convenience kits: BREAST IMAGING DYNJT5893 CHOG PLASTICS SYNJ10306A ENDO BREAST AUGMENTATION PACK DYNJ68023 FACIAL PLASTIC DYNJ909926C JVL - MODULE PLASTIC PK DYNJ84081B KIT MAJOR PLASTICS MOSES DYNJ905362C MEM MAXILLOFACIAL PACK-LF DYNJ0660040R MINOR BREAST PACK DYNJ89023A PLASTIC MAJOR SURGERY DYNJ902510M PLASTIC PACK DYNJ84766 PLASTIC PACK-LF DYNJ0578842M PLASTICS EXTREMITY PACK DYNJ63803C PLASTICS PK - NO SYR DYNJ62433D RR-ASC-RHINOPLASTY PACK-LF DYNJ81772C TRANSGENDER PACK DYNJT7588 WH PLASTIC MAJOR PACK DYNJ89048A
Z-2423-2026
Product summary
- Event
- Event 98951
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 49,654 kits total
- Official record key
device-enforcement:Z-2423-2026
Official wording
Reason: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Code information: DYNJT5893 UDI-DI 10198459517839 Lot 25KBA123 SYNJ10306A UDI-DI 10193489296891 Lots 25LBO305 26CBD081 DYNJ68023 UDI-DI 10193489468083 Lot 25KBI169 DYNJ909926C UDI-DI 10198459423109 Lots 25LBC067 25LBR659 DYNJ84081B UDI-DI 10198459462474 Lot 25LMI881 DYNJ905362C UDI-DI 10198459346842 Lots 25KBN239 25LBF694 DYNJ0660040R UDI-DI 10889942220083 Lots 25JME572 26AMA936 DYNJ89023A UDI-DI 10198459388316 Lot 25KBC500 DYNJ902510M UDI-DI 10198459683374 Lots 26CBM279 26CBO942 DYNJ84766 UDI-DI 10195327414108 Lot 26BBC049 DYNJ0578842M UDI-DI 10193489288292 Lot 25LMG027 DYNJ63803C UDI-DI 10198459149825 Lots 25LBN476 26CBC156 DYNJ62433D UDI-DI 10198459498176 Lots 25KBC752 25KBM917 DYNJ81772C UDI-DI 10198459349362 Lots 25LMH594 25LMI396 DYNJT7588 UDI-DI 10198459635182 Lot 26AMA250 DYNJ89048A UDI-DI 10198459388477 Lot 26BBD124
Distribution pattern: US Nationwide distribution. OUS distribution pending.
Derived failure modes
-
Unknown
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.