Recalls / —

—#136070

Product

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

FDA product code

KOC — Accessories, Blood Circuit, Hemodialysis

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K935958

Affected lot / code info

All lot numbers

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Fresenius Medical Care Holdings, Inc.

Address

920 Winter St, Waltham, Massachusetts 02451-1521

Distribution

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.

Timeline

Recall initiated

2015-04-27

Posted by FDA

2015-06-05

Terminated

2021-02-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #136070. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.