Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.
Check against the official notice below — it lists the full affected range.
Bausch & Lomb Inc. is recalling Bausch + Lomb Stellaris Elite 20 GA Vitrectomy Cutters, Model BL5626, because the back cap can separate from the body of the device. The affected product was distributed in 33 cases across 25 U.S. states, government facilities, and 15 international countries. The recall involves three specific lot numbers: V9400 (expiration 11/6/2018), W1439 (expiration 8/19/2019), and W1467 (expiration 8/26/2019).
The affected units are packaged in sterile pouches and can be identified by UDI 00757770058891. The source document does not specify a remedy or instructions for what affected consumers should do.
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: 33 cases Lot/code info: Lot numbers V9400, exp. 11/6/2018; W1439, exp. 8/19/2019; and W1467, exp. 8/26/2019, UDI 00757770058891.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.