BD Visitec High Viscosity Injector 6mm [Hammer] .90mm (20G) Catalog Number: 585184 High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and temporarily sutured into place.
FDA Recall Z-2160-2011 · Posted 2011-05-10
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Recalling FirmBecton Dickinson and Company
Recall StatusTerminated
Product CodeHMX
Date Initiated2010-12-17
Date Terminated2013-07-03
Product Quantity2545 units
Reason for Recall
Restricted or no fluid flow for Visitec High Viscosity Injector.
Firm Action
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
Distribution Pattern
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, New Zealand, China, UK, Germany, Russia, Belgium, Italy, France, Sweden, and Ireland.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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