Sorin CP5 Centrifugal Pump Recalled for Delayed Air Bubble Detection Response
Sorin Group is recalling CP5 Centrifugal Pumps because the automatic line closure after air bubble detection may take longer than intended.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device with a potential failure in a safety mechanism (air bubble detection/line closure), which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sorin Group Deutschland GmbH is recalling the CP5 Centrifugal Pump, which consists of a drive unit, emergency system, and pump control panel. The recall involves 1,318 units of Model No. 60-00-60. The device is used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sensor.
The recall is due to a possibility that the automatic line closure by the ERC clamp after the detection of an air bubble could take longer than is intended by design. This delay in the safety mechanism's response time is the specific defect identified in the recall notice.
The affected units were distributed domestically and internationally to numerous countries, including the United States, Canada, and various nations in Europe, Asia, and the Middle East. Users of the CP5 Centrifugal Pump should contact Sorin Group Deutschland GmbH for instructions on how to proceed with the recall.
The recalled product
- Product
- CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sensor.
- Manufacturer
- Sorin Group Deutschland GmbH
- Affected units
- 1,318
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 (4)
- Model No. 60-00-60. Drive Unit: Ref #60-01-04
- UDI 04033817900948. Emergency System: Ref #60-01-35
- UDI 04033817900955. Pump Control Panel: Ref #60-02-60
- UDI 04033817901006.
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Sorin Group Deutschland GmbH
See all →- HighSorin S5/C5 Heart-Lung Machine Recalled for Pump Control Failures
FDA (Devices) · 2014-02-05
- HighSorin CP5 Centrifugal Pump System Recalled for Control Knob Failures
FDA (Devices) · 2014-02-05
- HighSorin Recalls S5 Heart-Lung Machines Due to Cardioplegia Control Malfunction
FDA (Devices) · 2013-11-13
Similar recalls
- HighSorin CP5 Centrifugal Pump System Recalled for Control Knob Failures
FDA (Devices) · 2014-02-05
- HighSorin S5/C5 Heart-Lung Machine Recalled for Pump Control Failures
FDA (Devices) · 2014-02-05
- SevereSorin C5 Perfusion System Recalled for Motor Controller Fault
FDA (Devices) · 2012-11-14
- SevereSorin S5 Perfusion System Recalled for Motor Controller Faults
FDA (Devices) · 2012-11-14
- SevereSorin S5 Perfusion System Recalled for Motor Controller Fault
FDA (Devices) · 2012-11-14
- HighSorin SCP Pump Control Panel Recalled for Circuit Board Malfunction
FDA (Devices) · 2012-11-07