| Class 2 Device Recall BD Visitec High Viscosity Injector 4mm |  |
Date Initiated by Firm | December 17, 2010 |
Date Posted | May 10, 2011 |
Recall Status1 |
Terminated 3 on July 03, 2013 |
Recall Number | Z-2159-2011 |
Recall Event ID |
57472 |
Product Classification |
Cannula, ophthalmic - Product Code HMX
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Product | BD Visitec
High Viscosity Injector 4mm .90 (20G) [Hammer]
REF 585173
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. |
Code Information |
Lot #: 0006986, Exp Date: 2015-01; Lot #: 0048865, Exp. Date: 2015-02; Lot #: 0211585, Exp. Date: 2015-08; Lot #: 0244725, Exp. Date 2015-09 |
Recalling Firm/ Manufacturer |
Becton Dickinson and Company 411 Waverley Oaks Rd Ste 2229 Waltham MA 02452-8448
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For Additional Information Contact | 781-906-7950 |
Manufacturer Reason for Recall | Restricted or no fluid flow for Visitec High Viscosity Injector. |
FDA Determined Cause 2 | 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 in Commerce | 2480 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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