S5-7604 Silicone Oil Injection Cannula 4mm Long - 20G REF 585246 High Viscosity Injectors are used during retinal surger

FDA device recall Z-2163-2011 · posted 2011-05-10 · Terminated

Recall details

Recalling firm

Becton Dickinson and Company

Reason for recall

Restricted or no fluid flow for Visitec High Viscosity Injector.

Action taken

Beaver Visitec (BVI) notified customers via telephone and by sending an Urgent Recall Customer Notification letter dated December 7, 2010. The letter identified the product, the problem, and the action to be taken by the customer. , Customers were requested to return all unused product in their inventory for credit or refund and complete the attached Customer Response Form and return it by fax to 781-893-7957. Questions can be directed to Inside Sales Manager at 781-906-7952.

Root cause

Component change control

Status

Terminated

Product code

HMX

Quantity affected

1500 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Israel, Jordan, Russia, Saudi Arabia, South Africa, Turkey, Iraq, Lebanon, Morocco, Tunisia, Syria, India, Argentina, Australia, Austria,

Date initiated

2010-12-17

Date posted

2011-05-10

Date terminated

2013-07-03

Location

Waltham, MA