Z-3269-2018 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
- 19.33 cases
Product Description
Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid-Field Elite Pack, REF SE5423MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/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 W0147, exp. 2/26/2019; W0781, exp. 5/11/2019; W0870, exp. 6/4/2019; and W1721, 10/1/2019, UDI 00757770059423.