Home / Recalls / Medical Devices
Bausch & Lomb Inc recalls Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.
Recalled October 3, 2018 · FDA recall Z-3271-2018 · Bausch & Lomb
Hazard
The back cap separates from the body of the vitrectomy cutter. · FDA Class II
Units
131 cases
Sold at
Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.
Description
The back cap separates from the body of the vitrectomy cutter.
Product
Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.
Manufacturer(s)
Bausch & Lomb Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →