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U.S. Department of Health and Human Services

Class 2 Device Recall Visitec Anterior Chamber Cannula

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 Class 2 Recall
Visitec Anterior Chamber Cannula
see related information
Date Posted May 27, 2014
Recall Status1 Open
Recall Number Z-1664-2014
Recall Event ID 68281
Product Classification Cannula, Ophthalmic - Product Code HMX
Product Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended to irrigate and or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate. These products are used in all sections of the eye. This cannula is a general use cannula mainly designed for the precise maintenance of optimum anterior chamber depth
Code Information Lot number: 3079324
Recalling Firm/
Manufacturer
Beaver-Visitec International Inc.
411 Waverley Oaks Rd Ste 229
Waltham, Massachusetts 02452-8422
Manufacturer Reason
for Recall
Contains a sharp tip needle when the product should contain a blunt tip cannula
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Beaver Visitec (BVI) sent a Product Recall Notice dated May 6, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately return any un-opened product of the affected lot so that BVI can replace the product or issue credit to their company. Customers were asked to fax or email the customer response form to 866-906-4304 or claimsUS@beaver-visitec.com as acknowledgement of the letter. Customers with questions should call 781-906-7986. For questions regarding this recall call 781-906-7950.
Quantity in Commerce 9970 units
Distribution Nationwide Distribution including AL, CT, IN, NC, NY, TX, and VA.
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.
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