Recall Z-0765-2007 ยท HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Bausch & Lomb Inc
Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cutter, Catalog No. CX5825, packaged individually in a Tyvek pouch, 6/box, RX. The firm names on the label are Bausch & Lomb Incorporated, Rochester, NY, and Bausch & Lomb Incorporated, Kingston-upon-Thames, UK.
| Date | Apr 21, 2007 (initiated Feb 9, 2007) |
| Status | Terminated |
| Reason | The cutter probe tip breaks during use. |
| Root cause | Other |
| Action | On 2/12/07, express mail letters were addressed to operating room supervisors to notify them of the recall. Additional E-mail notifications were issued on 2/14/07 to doctors and letters were addressed to them on 2/20/07 to make them aware of the recall, although they do not directly receive the product. The communications instructed them to not use the affected product and to return it, along with the business reply card. |
| Quantity | 32,190 units of Catalog No: CX 5825 |
| Distribution | Class II Recall - Worldwide Distribution --- USA including states of MO, NC, FL, CA, and TX and countries of Canada, China, Japan, Australia, Hong Kong, India, Singapore, Korea, Taiwan, Thailand, Argentina, Brazil, Mexico, and The Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980488 | STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM Storz Instrument Co., Mar 23, 1998 |