Sorin Group recalls CP5 centrifugal pumps with model 60-00-60 due to potential delay in automatic line closure after air bubble detection, which could cause system failure.
Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection of an air bubble could take longer than is intended by design in the CP5 system.
Sorin Group is recalling CP5 centrifugal pumps that may delay closing the fluid line after detecting an air bubble. This delay could lead to system failure if the pump is used in critical applications like medical equipment.
The pump's automatic line closure mechanism might take longer than intended when an air bubble is detected. This delay could cause fluid to continue flowing, potentially leading to system failure in medical applications.
Users of medical-grade CP5 centrifugal pumps with model number 60-00-60 are affected. Healthcare facilities and medical device users are most at risk due to potential system failure.
Check for model number 60-00-60 on the pump. The drive unit has reference number 60-01-04, emergency system 60-01-35, and pump control panel 60-02-60.
Identify the model number on the pump, which should be 60-00-60 for affected units.
The recall indicates a potential delay in automatic line closure after air bubble detection, but the pump is generally safe unless used in critical applications where this delay could cause system failure.
Check for model number 60-00-60 on the pump. The drive unit reference number is 60-01-04, emergency system 60-01-35, and pump control panel 60-02-60.
The recall does not specify a remedy, so users should check the model number and contact Sorin Group if they have concerns.
We’ve drafted a message you can send Sorin Group to request your refund or repair — edit it as you like.
Subject: Recall Z-0401-2018 — Sorin Group Sorin Group Hello, I own a Sorin Group that is covered by recall Z-0401-2018 from Sorin Group. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.