Terumo TenderFlow Pediatric Venous Cannulae — Class II medical device recall Z-2103-2014
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2014-07-30, distributed nationwide. During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose f
| Recall number | Z-2103-2014 |
|---|---|
| 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 | 2014-05-23 |
| Classified | 2014-07-22 |
| Reported by FDA | 2014-07-30 |
| Terminated | 2015-02-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CL, GB, JP, MX, MY, SG, TH, TW |
| Quantity | 14,380 units |
| Reason classes | specification failure |
| Lot numbers | AM000378, AM001309, AM001312, AM001315, AM002689, AM002697, AM002702, AM002705, AM002707, AM002708, AM002709, AM002717, AM002719, AM003778, AM004227, AM004268, AM006016, AM006018, AM006020, AM006046, AM006048, AM006050, AM006052, AM006072, AM007635, AM007636, AM007637, AM007639, AM007724, AM007725, AM007726, AM007732, AM007733, AM008235, AM017262, AM017681, AM017817, AM017924, AM018160, AM018316 |
| Model numbers | 813541, 813542, 813544, 813545, 813546, 813547, 813548, 813549, 813550, 813551, 813552, 813553, 813554, 813555, 813556, 813557, 813559, 813560, 813561, 813565, 813566 |
Product
Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" flare, Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual 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
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-2103-2014. 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.