Recall Z-0496-2007 ยท HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Bausch & Lomb Inc
Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack, Catalog #CX4920, containing 1/20-gauge high speed vitrectomy cutter as well as other accessories. Catalog #USSCX4920A is also included in the recall, which is used by customers for ordering only . There is no labeling associated with this catalog number. This catalog number is used for ordering Cat. #4920 along with Cat.
| Date | May 24, 2007 (initiated Dec 14, 2006) |
| Status | Terminated |
| Reason | The cutter tip could break during a procedure |
| Root cause | Other |
| Action | Recall letters were issued via e-mail to surgeons on 12/14/06 and via overnight mail on 12/14/06 to surgeons and operating room supervisors requesting immediate segregation and return of the product. |
| Quantity | Cat. CX4920 - 4,475 packs; and Cat. CX4920A - 40 packs |
| Distribution | Worldwide distribution ---- including USA and countries of Canada, China, Japan, Australia, Hong Kong, India, Malaysia, New Zealand, 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 |