Z-3176-2011

Terumo Sarns Level Sensor II Pads. Terumo Cardiovascular Systems Corporation. Used to attach level sensors to...

Name: Z-3176-2011 Terumo Sarns Level Sensor II Pads. Terumo Cardiovascular Systems Corporation. Used to attach level sensors to...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2011-08-12
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2011-08-12 / Terminated

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Sarns Level Sensor II Pads. Terumo Cardiovascular Systems Corporation. Used to attach level sensors to the sides of the venous reservoir on 2011-08-12. The reason FDA records is "Level Sensor II mounting pads may not stick to the venous reservoir and may detach either at case setup or during a case". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3176-2011
Status: Terminated
Initiated: 2011-08-12
Posted: 2011-09-09
Terminated: 2012-06-20
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Sarns Level Sensor II Pads. Terumo Cardiovascular Systems Corporation. Used to attach level sensors to the sides of the venous reservoir.
Product code: KRI Accessory Equipment, Cardiopulmonary Bypass
Reason for recall: Level Sensor II mounting pads may not stick to the venous reservoir and may detach either at case setup or during a case.
FDA root cause: Incorrect or no expiration date
Action: Terumo Cardiovascular Systems Corp. sent an "Urgent Medical Device Removal" notice dated August 10, 2011 to all affected customers. The notice instructs customers to discard all remaining level sensor pads that do not have an expiration date on the package, and notify Terumo of the number of affected pads via a response form. Terumo will replace recalled product. For questions on this recall call Terumo Customer Service at (800) 521-2818, 8 am-6 pm EST.
Quantity in commerce: 1,531,440 devices
Distribution: Worldwide Distribution -- Nationwide Distribution, and the island of Puerto Rico.
Product codes and lots: Product code: 195240 Batch Numbers 616814, 618558, 619369, and 619396. Lot codes: 123360, 129471, 29371-1, 29371-2, 36281, 40406, 42244, 44233, 49385, 51662, 56778, 58289, 61740, 64408, 68194, 70674, 75069, 78925, 80039, 82191, 86889, 90106, 90332, 91899, 98907, 99493, 99495, 101524, 105072, and 105808.

Product code KRI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)