FDA Recall Terminated

Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic

Recall: Z-1632-2013 · Initiated May 3, 2013

Recall

Recall Number: Z-1632-2013
Event Number: 65205
Firm: Surgical Instrument Service And Savings, Inc.
FEI Number: 3002299608
Product Code: HRH
Status: Terminated
Root Cause: Packaging process control
Initiated: May 3, 2013
Posted: July 1, 2013
Terminated: July 11, 2013
Address: 2747 Sw 6th St, Redmond, OR, 97756-7109

Description

Reason

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Action

MEDISISS sent a Correction Immediate Action Request letter dated May 2, 2013, to all affected customes. The letter identified the product, the problem, and the action to be taken by the customer. The letter directed the customer to inspect the products prior to use for seal integrity as specified on the product labeling: "Sterile unless package has been damaged or opened. Do not use if package is damaged." This will be followed up by a visit from the customer's sales representatives who are tasked with inspecting all the lots that may be remaining in the customer's inventory. The sales representative is directed to complete a "Verification of Seal Inspection" form and return it to MEDISISS Customer Relations. Devices with unacceptable seals are to be returned to MEDISISS. The sales representative is responsible for obtaining a shipping label from customer service to enable the devices to be returned to the recalling firm via Fed Ex. Customers with questions were instructed to call 866-866-7477.

Distribution

Nationwide Distribution.

Quantity