Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended to irrigate and or aspirate opht

FDA device recall Z-1664-2014 · posted 2014-05-27 · Terminated

Recall details

Recalling firm

Beaver-Visitec International Inc.

Reason for recall

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

Action taken

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.

Root cause

Packaging process control

Status

Terminated

Product code

HMX

Quantity affected

9970 units

Distribution

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

Date initiated

2014-05-06

Date posted

2014-05-27

Date terminated

2014-09-05

Location

Waltham, MA