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FDA (Device enforcement)Recalled 2018-08-08closedclass ii

Bausch & Lomb Inc: Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper.

Is my product affected?

Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper.

  • UPC 00757770058907

Check against the official notice below — it lists the full affected range.

What happened

Bausch & Lomb Inc. recalled Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627 devices because the back cap can separate from the body of the vitrectomy cutter. The affected devices were distributed to 25 U.S. states, several foreign countries including Russia, France, and Thailand, and government facilities. The recall involved approximately 103.33 cases across four lot numbers with expiration dates ranging from October 2018 to August 2019.

The recall record does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The back cap separates from the body of the vitrectomy cutter.

Details from the source

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: 103.33 cases Lot/code info: Lot numbers V9300, exp. 10/17/2018; V9807, exp. 1/7/2019; W0019, exp. 2/5/2019; and W1468, exp. 8/26/2019, UDI 00757770058907.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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