Sarns" Venous Return Cannulae — Class II medical device recall Z-0196-2014
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2013-11-20, distributed in CA, DC, LA, MA, MI, MO, OK, TX…. During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose f
| Recall number | Z-0196-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States |
| Recall initiated | 2013-10-23 |
| Classified | 2013-11-08 |
| Reported by FDA | 2013-11-20 |
| Terminated | 2014-07-18 |
| Distributed | CA, DC, LA, MA, MI, MO, OK, TX, WI |
| Countries outside the US | CA |
| Quantity | 40 units |
| Reason classes | specification failure |
| Lot numbers | 0689812 |
| Model numbers | 9473 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0196-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.