FDA Recall Terminated

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

Recall: Z-0022-2009 · Initiated September 15, 2008

Recall

Recall Number
Z-0022-2009
Event Number
49436
Firm
Becton Dickinson and Company
FEI Number
1211998
Product Code
HMX
Status
Terminated
Root Cause
Employee error
Initiated
September 15, 2008
Posted
October 3, 2008
Terminated
February 29, 2012
Address
411 Waverley Oaks Rd, Ste 2229, Waltham, MA, 02452-8448

Description

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

Reason

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

Action

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.

Distribution

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

Quantity

1485 units