CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
FDA device recall Z-1716-2015 · posted 2015-06-05 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Blood chamber connection leaks during the use of the CRIT-LINE Blood Chamber
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- KOC
- Quantity affected
- 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.
- Date initiated
- 2015-04-27
- Date posted
- 2015-06-05
- Date terminated
- 2021-02-18
- Location
- Waltham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CRIT-LINE BLOOD CHAMBER WITH E-BEAM (K935958) | In-Line Diagnostics Corp. | 1995-01-19 |