Sarns Dual-stage Venous Return Cannulae — Class II medical device recall Z-1223-2014
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2014-03-26, distributed in CA, CT, FL, GA, IL, IN, LA, MI…. During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on cer
| Recall number | Z-1223-2014 |
|---|---|
| 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 | 2014-03-03 |
| Classified | 2014-03-18 |
| Reported by FDA | 2014-03-26 |
| Terminated | 2014-08-12 |
| Distributed | CA, CT, FL, GA, IL, IN, LA, MI, MN, MO, NC, NY, PA, TN, TX |
| Countries outside the US | AE, BE, CA, JP, MX, MY, TH, TW |
| Model numbers | 16472 |
Product
Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Reason for recall
During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage 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-1223-2014. 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.