Sorin CP5 Centrifugal Pump System Recalled for Control Knob Failures
Sorin Group is recalling 75 CP5 centrifugal pump systems due to reports of pump speed control knob failures that result in no response.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device used during cardiopulmonary bypass where a control failure could lead to harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Sorin Group Deutschland GmbH is initiating a field correction for the CP5 centrifugal pump system, part of the Stockert S5/Sorin C5 System. This system is intended for use during cardiopulmonary bypass for procedures lasting six hours or less. The recall involves 75 units distributed nationwide in the US and Puerto Rico, as well as internationally to numerous countries including Belgium, Spain, Finland, and the United Kingdom.
The recall is being conducted due to reports of pump speed control knob failures that result in no response. This defect could affect the operation of the centrifugal pump during medical procedures.
Healthcare facilities and users of the affected devices should contact Sorin Group for further instructions regarding the field correction. The specific item number for the affected product is 60-02-60.
The recalled product
- Product
- CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
- Manufacturer
- Sorin Group Deutschland GmbH
- Affected units
- 75
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Item Number: 60-02-60
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Sorin Group Deutschland GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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