Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1716-2015 · Posted 2015-06-05

Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeKOC
Date Initiated2015-04-27
Date Terminated2021-02-18
Product Quantity22,640,288

Reason for Recall

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

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K935958CRIT-LINE BLOOD CHAMBER WITH E-BEAMIn-Line Diagnostics Corp. · 1995-01-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑