Recall Z-1664-2014 ยท HMX Cannula, Ophthalmic
Beaver-Visitec International Inc.
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
| Date | May 27, 2014 (initiated May 6, 2014) |
| Status | Terminated |
| Reason | Contains a sharp tip needle when the product should contain a blunt tip cannula |
| Root cause | Packaging process control |
| 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 claimsUS@beaver-visitec.com as acknowledgement of the letter. Customers with questions should call 781-906-7986. For questions regarding this recall call 781-906-79 |
| Quantity | 9970 units |
| Distribution | Nationwide Distribution including AL, CT, IN, NC, NY, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.