CLASS II Device recall · Reported 17 Jun 2015 · FDA Enforcement Report

Crit-line Blood Chamber- an accessory to the Crit line III recalled

Fresenius Medical Care Holdings is recalling Crit-line Blood Chamber- an accessory to the Crit line III- Monitors in real time blood, distributed nationwide in the US. The recall was initiated on 27 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lot numbers

Quantity recalled22,640,288

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1716-2015
FDA event ID: 71093
Recalling firm: Fresenius Medical Care Holdings, Waltham, MA
Classification: Class II
Status: Terminated
Recall initiated: 27 Apr 2015
FDA classified: 5 Jun 2015
Reported: 17 Jun 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Patient Monitors

Timeline

27 Apr 2015	Recall initiated by company
5 Jun 2015	Classified by FDA	+39 days
17 Jun 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution - Nationwide Distribution including Puerto Rico., and the countries of : Ireland, Spain, Slovenia, Great Britain, Netherlands, Norway, Mexico, Egypt, Czech Republic and Spain.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

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

Which lots are affected?

All lot numbers

Where was it sold?

Worldwide Distribution - Nationwide Distribution including Puerto Rico., and the countries of : Ireland, Spain, Slovenia, Great Britain, Netherlands, Norway, Mexico, Egypt, Czech Republic and Spain.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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