FDA Recall Terminated

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

Recall: Z-1664-2014 · Initiated May 6, 2014

Recall

Recall Number
Z-1664-2014
Event Number
68281
Firm
Beaver-Visitec International Inc.
FEI Number
1211998
Product Code
HMX
Status
Terminated
Root Cause
Packaging process control
Initiated
May 6, 2014
Posted
May 27, 2014
Terminated
September 5, 2014
Address
411 Waverley Oaks Rd, Ste 229, Waltham, MA, 02452-8422

Description

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

Reason

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

Action

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 [email protected] as acknowledgement of the letter. Customers with questions should call 781-906-7986. For questions regarding this recall call 781-906-7950.

Distribution

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

Quantity

9970 units