Z-3214-2011

Sarns 8000 Cardioplegia Monitor, Catalog Number 16414; also known as PROG COMP BD AMPRO 420 CPG 8K, Catalog...

Name: Z-3214-2011 Sarns 8000 Cardioplegia Monitor, Catalog Number 16414; also known as PROG COMP BD AMPRO 420 CPG 8K, Catalog...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2011-08-29
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2011-08-29 / Terminated

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Sarns 8000 Cardioplegia Monitor, Catalog Number 16414; also known as PROG COMP BD AMPRO 420 CPG 8K, Catalog Number 816373 The Sarns 8000 Cardioplegia Monitor... on 2011-08-29. The reason FDA records is "The Cardioplegia Monitor for the Sarns Modular Perfusion System 8000 may fail to track cardioplegia delivery volume". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3214-2011
Status: Terminated
Initiated: 2011-08-29
Posted: 2011-09-15
Terminated: 2013-03-08
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Sarns 8000 Cardioplegia Monitor, Catalog Number 16414; also known as PROG COMP BD AMPRO 420 CPG 8K, Catalog Number 816373 The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit.
Product code: DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type
Reason for recall: The Cardioplegia Monitor for the Sarns Modular Perfusion System 8000 may fail to track cardioplegia delivery volume.
FDA root cause: Component change control
Action: Terumo Cardiovascular Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated August 29, 2011 to all affected customers. The letter describes the product, problem, and action to be taken. The letter advises customers to make sure all users are aware of the notice. Customers are instructed to complete and return an attached Customer Response Form. Terumo will replace the software on all monitors of the affected product. Customers with questions or concerns should call Terumo CVS Customer Service 1-800-521-2818.
Quantity in commerce: 85
Distribution: Worldwide Distribution--USA (nationwide) including the states of AL, AR, CA, CO, GA, IL, IN, MS, NC, OH, TN, VA, and WI and countries of Belgium, Columbia, Hong Kong, India, Singapore, and Taiwan.
Product codes and lots: Cardioplegia Catalog Number 16414 and Serial Numbers 2060, 3305, 3763, 3823, 3834, 3835, 3851-3876, 3878-3899, 3901, 3902, 3904, 3906-3913, 3915-3933 and 3935. Also, catalog number 816373, Serial numbers 491212, 498329, 505891, 505892, 509307, 510221, 512688, 514493, 517238, 522537, 524438, 527767, 534182, 541101, 545173, 551503, 557425, 563225, 568962 and 576045.

Product code DWB

K960916Class IISams 8000 Cardioplegia Monitor3M Health Care, Sarns / cleared 1996-06-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)