—#127265

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

FDA product code: HMX — Cannula, Ophthalmic
Device class: Class 1
Medical specialty: Ophthalmic
Affected lot / code info: Lot number: 3079324

Why it was recalled

Contains a sharp tip needle when the product should contain a blunt tip cannula

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Beaver-Visitec International Inc.
Address: 411 Waverley Oaks Rd, Ste 229, Waltham, Massachusetts 02452-8422

Distribution

Distribution pattern: Nationwide Distribution including AL, CT, IN, NC, NY, TX, and VA.

Timeline

Recall initiated: 2014-05-06
Posted by FDA: 2014-05-27
Terminated: 2014-09-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127265. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.