FDAClass IIApril 24, 2013

HCS3011 AV Loop Kit For use with Transonic CO status recall

HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is…

Why was HCS3011 AV Loop Kit For use with Transonic CO status recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot numbers: 102810, 010311 and 111810.

Product
HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is…
Recalling firm
Transonic Systems Inc
Quantity
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.
Recall date
April 24, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls