FDAClass IIOctober 3, 2018

Bausch + Lomb Stellaris Elite 25 GA Vit Cutter recall

Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.

Why was Bausch + Lomb Stellaris Elite 25 GA Vit Cutter recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.
Recalling firm
Bausch & Lomb Inc
Quantity
131 cases
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.
Recall date
October 3, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls