Safety monitor included with System 8000 Base The recall
Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal…
Why was Safety monitor included with System 8000 Base The recalled?
Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai that the safety monitors were tripping off. Terumo CVS' investigation determined that 8 monitors were manufactured with an underrated circuit breaker due to an error where an associate pulled an underrated circuit breaker from an incorrect inventory location. Since this time, inventory locations hav
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?
catalog number 16404 and serial numbers: 4357, 4381, 4386, 4387, 4389, 4391, and 4392.
- Product
- Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal…
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 8
- Distribution
- Worldwide distribution: International only-country of: Terumo Dubai, UAE
- Recall date
- September 19, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)