—#96306

Product

BD Visitec High Viscosity Injector 4mm [Hammer] .90 (20G) Catalog Number: 585208 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 product code: HMX — Cannula, Ophthalmic
Device class: Class 1
Medical specialty: Ophthalmic
Affected lot / code info: Lot #: 9314527, Exp Date: 2014-11; Lot #: 9347069, Exp Date: 2014-12; Lot #: 0019451, Exp Date: 2015-01; Lot #: 0048864, Exp Date: 2015-02; Lot #: 0111511, Exp. Date: 2015-04 Lot #: 0193966, Exp Date: 2015-01; Lot #: 0288626, Exp Date: 2015-01; Lot #: 0305287, Exp. Date: 2015-11

Why it was recalled

Restricted or no fluid flow for Visitec High Viscosity Injector.

Root cause (FDA determination)

Component change control

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson and Company
Address: 411 Waverley Oaks Rd, Ste 2229, Waltham, Massachusetts 02452-8448

Distribution

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.

Timeline

Recall initiated: 2010-12-17
Posted by FDA: 2011-05-10
Terminated: 2013-07-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96306. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.