Sarns" Soft-Flow Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0
FDA device recall Z-0195-2014 · posted 2013-11-08 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow Aortic Cannulae and Sarns" Venous Return Cannulae.
- Action taken
- On 10/23/13, Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE RECALL LETTER to their consignees. The letter identified the reason for the device removal, identified the affected product and associated potential hazards, and provided recall instructions to their customers regarding affected product return. Questions regarding this recall are directed to CVS Customer Service M-F, 8am-6pm at 1-800-521-2818.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 30 units
- Distribution
- Worldwide Distribution-USA including DC and the states of MO,TX,OK, LA, MA, CA, WI, and MI and the country of Canada.
- Date initiated
- 2013-10-23
- Date posted
- 2013-11-08
- Date terminated
- 2014-07-18
- Location
- Ann Arbor, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SARNS LOW JETTING AORTIC ARCH CANNULA (K934127) | 3M Health Care, Sarns | 1994-02-22 |