Recalls / —

—#73320

Product

BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.

FDA product code

HMX — Cannula, Ophthalmic

Device class

Class 1

Medical specialty

Ophthalmic

Affected lot / code info

Lot Number: 8018591

Why it was recalled

Product labeled as 4 mm High Viscosity Injector tip contains a 6 mm tip.

Root cause (FDA determination)

Employee error

Action the firm took

BD contacted accounts by telephone on 9/15/08 requesting users to discard units and complete the response form. Contact Becton Dickinson and Co. at 1-781-906-7950 for assistance.

Recalling firm

Firm

Becton Dickinson and Company

Address

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

Distribution

Distribution pattern

AZ, CA, CO, IL, OH, FL, PA , TN, TX,and VA Foreign: Australia and Japan.

Timeline

Recall initiated

2008-09-15

Posted by FDA

2008-10-03

Terminated

2012-02-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #73320. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.