Recall Z-1663-2010 ยท NFJ System, Image Management, Ophthalmic
Bausch & Lomb Inc
Bausch & Lomb Millennium Microsurgical System.
| Date | May 26, 2010 (initiated Jan 15, 2010) |
| Status | Terminated |
| Reason | The AC power cords used on these products are subject to an FDA Alert -- Safety Investigation of Certain Medical Device Power Cords: Initial Communication, Date Issued: October 19, 2009. |
| Root cause | Nonconforming Material/Component |
| Action | A "URGENT: POWER CORD RECALL" letter and copies of the FDA Alert dated Oct. 19, 2009 were sent to all customers on or about Jan. 15, 2010, by Stericycle, a recall notification service. The letter describes the product, problem and actions to be taken by the customers as well as FDA's recommendations and actions. The customers were made aware of the FDA Alert concerning the AC power cords and notified that these power cords were used in the devices. They were requested to inspect the power cords for damage and notify the recalling firm if damage is noted or if they have experienced sparking, |
| Quantity | Quantity never provided by firm |
| Distribution | Worldwide distribution: United States & Puerto Rico; Venezuela, India, Trinidad and Tobago, Colombia, Sri Lanka, Hong Kong, Vietnam, and Peru. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961310 | STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES) Storz Instrument Co., Jun 27, 1996 |