HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status

FDA device recall Z-1147-2013 · posted 2013-04-18 · Terminated

Recall details

Recalling firm

Transonic Systems Inc

Reason for recall

Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

DXG

Quantity affected

195 units total (140 units Domestic, 55 units Foreign)

Distribution

Worldwide Distribution - USA Nationwide including the states of AZ, CA, FL, GA, NM, NY, TX, VA and WA and countries of Netherlands, Canada and Russia.

Date initiated

2013-03-28

Date posted

2013-04-18

Date terminated

2014-03-05

Location

Ithaca, NY

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