FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: Terumo Sarns Level Sensor II Pads. Terumo Cardiovascular Systems Corporation. Used to attach level sensors to the sides of the venous reservoir.
- Recall number
- Z-3176-2011
- 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.
- Status
- Terminated
- Initiated
- 2011-08-12
- Posted
- 2011-09-09
- Terminated
- 2012-06-20
- Reason
- Level Sensor II mounting pads may not stick to the venous reservoir and may detach either at case setup or during a case.
- 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
- 1,531,440 devices
- Distribution
- Worldwide Distribution -- Nationwide Distribution, and the island of Puerto Rico.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KRI
- Firm FEI
- 1828100
- Firm city
- Ann Arbor
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28