Device Recall Instratek Carpal Tunnel Release Blades 의 리콜

Recall

65205

Class 2

Z-1623-2013

2013-05-03

2013-07-01

Terminated

United States

2013-07-11

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118229

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

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.