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U.S. Department of Health and Human Services

Class 2 Device Recall BD Visitec High Viscosity Injector 4mm

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  Class 2 Device Recall BD Visitec High Viscosity Injector 4mm see related information
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
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
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
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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