Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.
Check against the official notice below — it lists the full affected range.
Bausch & Lomb has recalled Bausch + Lomb Stellaris Elite 25 GA Vit Cutter Model BL5628 units because the back cap can separate from the body of the vitrectomy cutter. The affected product was distributed across 25 U.S. states, as well as government facilities and 16 international countries. A total of 131 cases were involved, spanning lot numbers V9301 through W1675 with expiration dates ranging from October 2018 to September 2019.
The affected lot numbers are 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), identified by UDI 00757770058914. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The back cap separates from the body of the vitrectomy cutter.
Reason for recall: The back cap separates from the body of the vitrectomy cutter. Distribution: 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 Quantity: 131 cases Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.