—#98366

Product

BD Beaver XStar Safety 2.5mm Crescent Knife; REF 378234 Crescent blades are used in a variety of ophthalmic surgery. Product is a cataract surgery knife designed for optimal tunnel architecture.

FDA product code: H--NN
Affected lot / code info: Lot/serial number: 0333798

Why it was recalled

Loose blades in the handle of knives due to uncured epoxy.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Beaver Visitec International, Inc.sent an Urgent Recall Notification letter dated February 25, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all unused product and to complete a Customer Response Form (to be returned via fax to 866-906-4304. For questions regarding this recall call 781-906-7917.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA including AZ, MA, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, VA and the country of China

Timeline

Recall initiated: 2011-02-28
Posted by FDA: 2011-04-05
Terminated: 2012-06-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98366. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.