FDA Device recall Z-2096-2014
Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating Product Usage: The V…
- FDA Device
- Class II
- terminated
- Published 2014-07-30
On 2014-07-30 the FDA classified a Class II recall of Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating Product Usage: The V… 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2096-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-23 |
| Published | 2014-07-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
Product
Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual 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
Identifiers
| code_info | Part No. 4934, Lot #: 0655207, 0657317, 0666535, 0682313, 0697852; Part No. 4934X, Lot #: 0659445, 0696672; Part No. 49…Part No. 4934, Lot #: 0655207, 0657317, 0666535, 0682313, 0697852; Part No. 4934X, Lot #: 0659445, 0696672; Part No. 4935, Lot #: 0655206, 0656923, 0682315, 0685669, 0696718; Part No. 4936, Lot #: 0655292, 0665320, 0684443, 0684444, 0687492, 690459R & Part No. 4936X, Lot #: 0656438, 0661606, 683308R. |
|---|
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-2096-2014%22
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