Recalls / —

—#50690

Product

BD Visitec Irrigating Cytosome, for use in cataract surgery. Ref 581618

FDA product code

KYG — Device, Irrigation, Ocular Surgery

Device class

Class 1

Medical specialty

Ophthalmic

Affected lot / code info

Lot Number: 6181868

Why it was recalled

Mislabeled: Carton label incorrectly labeled as Ref 581618 (.40 X 16mm) , may contain product Ref 581617 (.50 x 16mm)

Root cause (FDA determination)

Other

Action the firm took

BD Opthalmic notifiied accounts by telephone on 3/2/07 and followed with letter. Accounts are requested to return product.

Recalling firm

Firm

Becton Dickinson and Company

Address

411 Waverley Oaks Rd, Ste 2229, Waltham, Massachusetts 02452-8448

Distribution

Distribution pattern

Nationwide.

Timeline

Recall initiated

2007-03-02

Posted by FDA

2007-03-29

Terminated

2008-03-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #50690. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.