SCP Pump Control Panel — Class II medical device recall Z-0167-2013
Terminated recall by Sorin Group USA, Inc., reported 2012-11-07, distributed nationwide. Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stocker
| Recall number | Z-0167-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sorin Group USA, Inc., Arvada, CO, United States |
| Recall initiated | 2012-09-20 |
| Classified | 2012-10-29 |
| Reported by FDA | 2012-11-07 |
| Terminated | 2013-01-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BE, CA, IN, JP, RU |
| Reason classes | specification failure, device malfunction |
| Serial numbers | 60S08954, 60S09131, 60S09133-60S09135, 60S09140-60S09142 |
Product
SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less.
Reason for recall
Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel . An out of specification circuit board component within the Panel may lead to a malfunction consisting of a blank or flashing display. The flow and pressure display information may also be incorrect after the malfunction.
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-0167-2013. 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.