Z-1716-2015Class II

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

Name: Z-1716-2015 CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2015-04-27
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2015-04-27 / Terminated

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021 on 2015-04-27. FDA classified it as Class II and gives the reason as "Blood chamber connection leaks during the use of the CRIT-LINE Blood Chamber". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1716-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-27
Posted: 2015-06-05
Terminated: 2021-02-18
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
Product code: KOC Accessories, Blood Circuit, Hemodialysis
Reason for recall: Blood chamber connection leaks during the use of the CRIT-LINE Blood Chamber
FDA root cause: Under Investigation by firm
Action: Fresenius LLC North America notified accounts by letter sent certified mail on May 22, 2015, expanding the recall to All lots. Previously recall letters were on April 30, 2015, 2nd notice on May 14, 2015. Users are requested to examine inventory, discontinue use and return product. Contact FMCRTG, LLC Customer Service Team 1-800-323-5188 for instructions. A reply form is included as part of the customer communication with instructions to fill out and return via fax or scanned/emailed copy. Confirmation of delivery will be obtained through the use of registered mail.
Quantity in commerce: 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.
Product codes and lots: All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1716-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1716-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-05

Product code KOC

K935958Class IICrit-Line Blood Chamber with E-BeamIn-Line Diagnostics Corp. / cleared 1995-01-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)