FDA Device recall Z-2106-2014
CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannu…
- FDA Device
- Class II
- terminated
- Published 2014-07-30
On 2014-07-30 the FDA classified a Class II recall of CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannu… 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-2106-2014 |
| 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
CPB Catheter Kit 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
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. 80003-02, Lot #: PG11, QC11, QL09 & Part No. 80002-03, Lot #: PG11, QL09 |
|---|
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-2106-2014%22
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