FDA Device recall Z-0196-2014
Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long
- FDA Device
- Class II
- terminated
- Published 2013-11-20
On 2013-11-20 the FDA classified a Class II recall of Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long by Terumo Cardiovascular Systems, citing during an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on cer….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0196-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-23 |
| Published | 2013-11-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | CA, DC, LA, MA, MI, MO, OK, TX, WI |
Product
Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. Indicated for venous drainage during cardiopulmonary bypass surgery for dial cannulation of the superior and inferior vena cava.
Reason
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.
Identifiers
| code_info | Catalog Number 9473 Lot Numbers 0689812 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0196-2014%22
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