Device Recall AV Loop Kit 의 리콜

Recall

64770

Class 2

Z-1147-2013

2013-03-28

2013-04-18

Terminated

United States

2014-03-05

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117016

Transonic systems inc. have received complaints of blood leakage involving the av loop kit.

Transonic Systems Inc. sent an Urgent: Medical Device Recall dated March 27, 2013 to all affected customers. The letter identified the recalled product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine, discontinue use and return any recalled product via FedEx. Transonic Systems Inc. has offered to reimburse the firm for the return of these recalled products by check or credit memo for the returned goods and postage. Transonic Systems Inc. has requested that if a firm has further distributed any of the above lots, that they immediately contact their accounts, inform them of the recall, and have them return their outstanding recalled stocks to you. Transonic Systems Inc. have included copies of the product labeling and a Recall Return Response Form in their packet. Completed Recall Return Response Forms should be faxed to 607-257-5310.