Z-3265-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 3, 2018
- Initiation Date
- August 8, 2018
- Termination Date
- August 28, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33 cases
Product Description
Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.
Reason for Recall
The back cap separates from the body of the vitrectomy cutter.
Distribution Pattern
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.
Code Information
Lot numbers V9400, exp. 11/6/2018; W1439, exp. 8/19/2019; and W1467, exp. 8/26/2019, UDI 00757770058891.