Recall Z-2163-2011 ยท HMX Cannula, Ophthalmic
Becton Dickinson and Company
S5-7604 Silicone Oil Injection Cannula 4mm Long - 20G REF 585246 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
| Date | May 10, 2011 (initiated Dec 17, 2010) |
| Status | Terminated |
| Reason | Restricted or no fluid flow for Visitec High Viscosity Injector. |
| Root cause | Component change control |
| 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. |
| Quantity | 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, New Zealand, China, UK, Germany, Russia, Belgium, Italy, France, Sweden, and Ireland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.