CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Revers
FDA device recall Z-0859-2009 · posted 2009-01-23 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care North America
- Reason for recall
- Port may crack and separate resulting in potential blood exposure/blood loss for the patient
- Action taken
- Fresenius Medical contacted customers by e-mail,telephone and hard copy letter advising users to immediately discontinue use and return inventory. All internal customers were emailed on 11/25/08. All external customers were US Certified Mailed on 11/26/08. All internal customers were US Certified Mailed on 12/2/08 & 12/3/08.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KOC
- Quantity affected
- 57 units
- Distribution
- Worldwide Distribution --- including USA and country of Canada.
- Date initiated
- 2008-11-25
- Date posted
- 2009-01-23
- Date terminated
- 2009-09-24
- Location
- Waltham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR (K022536) | Fresenius Medical Care | 2002-10-30 |