Terumo Advanced Perfusion Assembly Pump Guts recall
Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in the…
Why was Terumo Advanced Perfusion Assembly Pump Guts recalled?
These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pulley of the roller pump. Prolonged use of a roller pump in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: 880559 880560 882808 882809 882810 882811 882812 882813 885541 885542 885543
- Product
- Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in the…
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 11
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CT, FL, LA, MA, MI, NY, and TX. Countries of Hong Kong, India, South Korea, and Taiwan.
- Recall date
- February 19, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)