System 8000 Base Product Usage: The Sarns Modular recall: Labeling Error
System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of…
Why was System 8000 Base Product Usage: The Sarns Modular recalled?
During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sarns" System 8000 bases were manufactured and distributed from 11/13/06-11/29/06 with an incorrect incorrect amperage rating identified on the name plate label. The mislabeling was identified in January 2007 a set up process of the automark label printer. All units were corrected in the field in Marc
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: 16401 and serial number: 2001, 2002, and 2003.
- Product
- System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of…
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 3
- Distribution
- US Nationwide Distribution - including the state of New York
- Recall date
- August 22, 2012
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)