CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
This recall has been terminated (originally issued June 5, 2015).
- Recall Initiated
- April 27, 2015
- Posted
- June 5, 2015
- Terminated
- February 18, 2021
- Recall Number
- Z-1716-2015
- Quantity
- 22,640,288
- Firm Location
- Waltham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Blood chamber connection leaks during the use of the CRIT-LINE Blood Chamber
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.
Lot / Code Info
All lot numbers
Root Cause
Under Investigation by firm
Action Taken
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.