BD Beaver XStar Safety 2.5mm Crescent Knife; REF 378234 Crescent blades are used in a variety of ophthalmic surgery. Pro

FDA device recall Z-1894-2011 · posted 2011-04-05 · Terminated

Recall details

Recalling firm

Beaver-Visitec International Inc.

Reason for recall

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

H--NN

Quantity affected

1680 units (1130 domestic, 550 foreign)

Distribution

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

Date initiated

2011-02-28

Date posted

2011-04-05

Date terminated

2012-06-14

Location

Waltham, MA