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

FDA device recall Z-3176-2011 · posted 2011-09-09 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

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.

Action taken

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.

Root cause

Incorrect or no expiration date

Status

Terminated

Product code

KRI

Quantity affected

1,531,440 devices

Distribution

Worldwide Distribution -- Nationwide Distribution, and the island of Puerto Rico.

Date initiated

2011-08-12

Date posted

2011-09-09

Date terminated

2012-06-20

Location

Ann Arbor, MI