Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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 Recall Z-1894-2011 · Posted 2011-04-05

Recalling FirmBeaver-Visitec International Inc.
Recall StatusTerminated
Product CodeH--NN
Date Initiated2011-02-28
Date Terminated2012-06-14
Product Quantity1680 units (1130 domestic, 550 foreign)

Reason for Recall

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

Firm Action

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

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑