BD Visitec EdgeAhead MVR Knife, BD Opthalmic Systems, Waltham, MA. Intended for use in cataract surgery to create self-s

FDA device recall Z-1597-2010 · posted 2010-05-13 · Terminated

Recall details

Recalling firm

Becton Dickinson and Company

Reason for recall

A field action was initiated due to a recent customer complaint from Japan there is a labeling mixup and that some of the BD Visitec EdgeAhead MVR Knife 0.90mm (20G), REF 585230, shelf packs may contain BD Visitec EdgeAhead Slit Knife 2.3mm (40 degree), REF 8009918.

Action taken

BD Medical issued a "Voluntary Advisory Notice" dated April 6, 2010. Consignees were informed of the affected product and asked to complete the enclosed Customer Response Form indicating whether the product will be returned to the firm. For further information, contact BD Medical Opthalmic Systems at 1-781-906-7952 or via email at ahusebo@bd.com.

Root cause

Packaging process control

Status

Terminated

Product code

HNN

Quantity affected

1170 (US 810, OUS 360)

Distribution

Worldwide Distribution -- United States, Canada and Japan.

Date initiated

2010-04-06

Date posted

2010-05-13

Date terminated

2012-08-06

Location

Waltham, MA