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.
FDA Recall Z-0765-2007 · Posted 2007-04-21
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Recalling FirmBausch & Lomb Inc
Recall StatusTerminated
Product CodeHQE
Date Initiated2007-02-09
Date Terminated2009-04-07
Product Quantity32,190 units of Catalog No: CX 5825
Reason for Recall
The cutter probe tip breaks during use.
Firm 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.
Root Cause
Other
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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