Recall Z-1716-2015 ยท KOC Accessories, Blood Circuit, Hemodialysis
Fresenius Medical Care Holdings, Inc.
CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
| Date | Jun 5, 2015 (initiated Apr 27, 2015) |
| Status | Terminated |
| Reason | Blood chamber connection leaks during the use of the CRIT-LINE Blood Chamber |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935958 | CRIT-LINE BLOOD CHAMBER WITH E-BEAM In-Line Diagnostics Corp., Jan 19, 1995 |