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Terminated

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

FDA Recall Z-3176-2011 · Posted 2011-09-09

Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeKRI
Date Initiated2011-08-12
Date Terminated2012-06-20
Product Quantity1,531,440 devices

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.

Firm 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.

Root Cause

Incorrect or no expiration date

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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