Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous… — Class II medical device recall Z-0071-2013
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2012-10-24, distributed nationwide. Backplate reservoir holders were manufactured with an incorrect configuration of connector supports. The devic
| Recall number | Z-0071-2013 |
|---|---|
| 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 | 2009-10-02 |
| Classified | 2012-10-16 |
| Reported by FDA | 2012-10-24 |
| Terminated | 2013-01-29 |
| Distributed | Nationwide (US) |
| Quantity | 33 units |
| Model numbers | 816280 |
Product
Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible reservoir by strategically placed mounting arms. Additionally, there are three port supports the user incorporates to position the lines that enter and exit the venous bag. The Backplate/Holder is designed to allow the user to move the port support location to accommodate different tubing circuit designs to permit mounting flexibility.
Reason for recall
Backplate reservoir holders were manufactured with an incorrect configuration of connector supports. The devices were manufactured and configured with two 3/8 inch and one ¿ inch connector supports instead of one 3/8 inch and two ¿ inch connector supports (See location of supports as # 7 and # 8 on backplate attachment). The backplates were manufactured as described in manufacturing instructions a
Machine access
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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.