Bausch & Lomb Millennium TSV 25 Ga. High Speed Posterior Vitrectomy Pack, Catalog No: CX4925, containing 1/25-ga. cutter
FDA device recall Z-0766-2007 · posted 2007-04-21 · Terminated
Recall details
- Recalling firm
- Bausch & Lomb Inc
- Reason for recall
- The cutter probe tip breaks during use.
- Action taken
- 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
- Status
- Terminated
- Product code
- HQE
- Quantity affected
- 13,685 units of Catalog No: CX4925
- 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, Arge
- Date initiated
- 2007-02-09
- Date posted
- 2007-04-21
- Date terminated
- 2009-04-07
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM (K980488) | Storz Instrument Co. | 1998-03-23 |