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U.S. Department of Health and Human Services

Class 2 Device Recall BD 1 OVD Sodium Hyaluronate

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 Class 2 Recall
BD 1 OVD Sodium Hyaluronate
see related information
Date Posted December 16, 2010
Recall Status1 Terminated on February 16, 2012
Recall Number Z-0606-2011
Recall Event ID 57104
Premarket Approval
PMA Number
P960011
Product Classification Aid, Surgical, Viscoelastic - Product Code LZP
Product Beaver-Visitec International (Beaver-Visitec) BD 1% OVD Sodium Hyaluronate, 10 mg/ml 1.0 mL. Sterile. Rx For Intraocular Use REF 585304 Use as a surgical aid to protect corneal endothelium during cataract extraction procedures, intraocular lens implantation and anterior segment surgery.
Code Information Lot No. Exp. Date RDOl71B 2012-12; RD0070A 2012-05; RD0018A 2012-02; RD0007A 2012-01 RC0064C 2011-06; RC0004A 2011-01;
Recalling Firm/
Manufacturer
Becton Dickinson and Company
411 Waverley Oaks Rd Ste 2229
Waltham, Massachusetts 02452-8448
For Additional Information Contact John C. Kim
973-796-1730
Manufacturer Reason
for Recall
Finger flange on the BD 1% OVD syringe can disengage during cataract surgery and and may lead to injury.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action Beaver Visitec issued an Urgent: Field Safety Notice letter, dated 10/4/10 to direct accounts, identifying the affected product and informing users of the potential for the finger grip to disengage during use. The firm offers solutions as follows: Allow the finger grip to remain attached to the syringe and continue to use the product. Position the open side of the finger grip towards the palm to avoid detachment of the grip from the syringe. Remove the finger grip and continue to use the product. Return the unused product to Beaver-Visitec for reimbursement. Users were requested to complete the Customer Response Form. Questions can be directed to: Inside Sales at 781-906-7952.
Quantity in Commerce 72278 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LZP and Applicant = BIO-TECHNOLOGY GENERAL CORP.
PMAs with Product Code = LZP and Applicant = FERRING PHARMACEUTICALS, INC.
PMAs with Product Code = LZP and Applicant = IOLTECH
PMAs with Product Code = LZP and Applicant = SAVIENT PHARMACEUTICALS, INC
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