FDAClass IIJune 17, 2015

CRIT-LINE Blood Chamber- an accessory to the Crit line recall

CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021

Why was CRIT-LINE Blood Chamber- an accessory to the Crit line recalled?

Blood chamber connection leaks during the use of the CRIT-LINE¿ Blood Chamber

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?

All lot numbers

Product
CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
22,640,288
Distribution
Worldwide Distribution - Nationwide Distribution including Puerto Rico., and the countries of : Ireland, Spain, Slovenia, Great Britain, Netherlands, Norway, Mexico, Egypt, Czech Republic and Spain.
Recall date
June 17, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls