FDA has not published a risk classification for this recall yet.
- Recall #:
- 99115
- Lot/product code:
- Lot Code: GEM Premier 5000:
Part number: 00024019255
UDI: 08426950870227
Units distributed in US: 0 affected BCR wands on the GEM Premier 5000 in the US.
GEM Premier 5000 Serial Nos.: N/A
Units distributed in Hong Kong: 27 affected BCR wands on the GEM Premier 5000 in Hong Kong.
GEM Premier 5000 Serial Nos.: 20106073, 20106039, 19052933, 20116415, 20064792, 22062065, 22062067, 19103490, 22092716, 22102881, 18112339, 19012518, 20126582, 20075256, 20064794, 20106036, 24016057, 21088758, 21088759, 18061910, 24016081, 24016108, 24108036, 24108044, 24067370, 24067371 and 24077468.
Units distributed in United Kingdom: 67 affected BCR wands on the GEM Premier 5000 in the United Kingdom.
GEM Premier 5000 Serial Nos.: 25110547, 25100462, 25110522, 25100472, 25101897, 25101920, 25101931, 25122029, 26012032, 25122030, 26012033, 26012043, 25110523, 25110536, 25120550, 25069638, 23101109, 24011137, 25081799, 25081797, 25091839, 25091840, 25091864, 25091870, 25091868, 25091873, 25091880, 25091876, 25101886, 25101889, 25101887, 25101891, 25101907, 25101904, 25101912, 25101905, 25101917, 25101921, 25101926, 25101929, 25101934, 25101927, 25111968, 25121986, 25121985, 25121981, 25121984, 25121994, 25121995, 25121982, 25121993, 25121991, 25121999, 25121996, 16030255, 17060782, 17060784, 17060785, 17060789, 17060790, 17060797, 17111126, 17121258, 18011414, 20054515, 20054516 and 22082271.
Units distributed in Spain: 21 affected BCR wands on the GEM Premier 5000 in Spain.
GEM Premier 5000 Serial Nos.: 25028719, 18021546, 18021549, 26012036, 18051850, 23054764, 21068342, 25080219, 26010781, 25122012, 25041639, 25120558, 25079944, 25079943, 25028719, 25100485, 25079947, 25100483, 25100484, 21057870 and 26010710.
Units distributed in Argentina: 3 affected BCR wands on the GEM Premier 5000 in Argentina.
GEM Premier 5000 Serial Nos.: 25100466, 24097933 and 23064897.
Affected Accessory:
Bar Code Reader (BCR) Wand
Part number: 00024019255
UDI: 08426950870227
Units distributed in US: 0
Units distributed in Hong Kong: 27
Units distributed in Spain: 21
Units distributed in the United Kingdom: 67
Units distributed in Argentina: 3
- Recalling firm:
- Instrumentation Laboratory