Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.
Reported: October 3, 2018 Initiated: August 8, 2018 #Z-3271-2018
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.
Details
- Recalling Firm
- Bausch & Lomb Inc
- Units Affected
- 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.
- Location
- Saint Louis, MO
Frequently Asked Questions
What product was recalled? ▼
Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.. Recalled by Bausch & Lomb Inc. Units affected: 131 cases.
Why was this product recalled? ▼
The back cap separates from the body of the vitrectomy cutter.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 3, 2018. Severity: Moderate. Recall number: Z-3271-2018.
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