Z-3271-2018 Class II Terminated
FDA device recall Z-3271-2018 was initiated by Bausch & Lomb Inc on August 8, 2018 and is designated Class II. Reason for recall: The back cap separates from the body of the vitrectomy cutter. The recall status is terminated (terminated August 28, 2019). Affected quantity: 131 cases.
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
- 131 cases
Product Description
Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 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 V9301, exp. 10/17/2018; V9401, exp. 11/6/2018; V9708, exp. 12/4/2018; W1019, exp. 6/23/2019; and W1675, exp. 9/24/2019, UDI 00757770058914.