Recall Z-2164-2011
Becton Dickinson and Company · initiated December 17, 2010
Product
S5-7606 Silicone Oil injection Cannula 6mm Long - 20G REF 585247 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
Codes / lots: Lot #: 0106448 Exp. Date: 2015-04
Reason for recall
Restricted or no fluid flow for Visitec High Viscosity Injector.
FDA-determined cause: Component change control
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.
Details
- Recall number
- Z-2164-2011
- Initiated
- December 17, 2010
- Posted by FDA
- May 10, 2011
- Terminated
- July 3, 2013
- Product code
- HMX – Cannula, Ophthalmic
- Quantity
- 1000 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, New Zealand, China, UK, Germany, Russia, Belgium, Italy, France, Sweden, and Ireland.
- Recalling firm
- Becton Dickinson and Company, Waltham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2159-2011 | BD Visitec High Viscosity Injector 4mm .90 (20G) [Hammer] REF 585173 High Viscosity…Restricted or no fluid flow for Visitec High Viscosity Injector. | 12/17/2010Terminated |
| Z-2160-2011 | BD Visitec High Viscosity Injector 6mm [Hammer] .90mm (20G) Catalog Number: 585184 High…Restricted or no fluid flow for Visitec High Viscosity Injector. | 12/17/2010Terminated |
| Z-2161-2011 | BD Visitec High Viscosity Injector 4mm [Hammer] .90 (20G) Catalog Number: 585208 High…Restricted or no fluid flow for Visitec High Viscosity Injector. | 12/17/2010Terminated |
| Z-2162-2011 | BD Visitec High Viscosity Injector 6mm .90mm (20G) [Hammer] Catalog Number: 585228 High…Restricted or no fluid flow for Visitec High Viscosity Injector. | 12/17/2010Terminated |
| Z-2163-2011 | S5-7604 Silicone Oil Injection Cannula 4mm Long - 20G REF 585246 High Viscosity…Restricted or no fluid flow for Visitec High Viscosity Injector. | 12/17/2010Terminated |