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Terminated

Sarns Rigid Intracardiac Sucker. The subject device is a single use, sterile device with a 7.0 mm (21 FR) tip and 1/4 connector

FDA Recall Z-0053-2012 · Posted 2011-10-17

Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDTS
Date Initiated2011-09-13
Date Terminated2012-12-10
Product Quantity9770

Reason for Recall

Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns" Adult Rigid Intracardiac Sucker.

Firm Action

On 9/13/2011 Terumo sent a letter entitled "URGENT MEDICAL DEVICE REMOVAL" to its customers that included the name and description of the device, lot numbers, the potential hazard, correction, the reason for the recall and instructions. Customers are to review the notice, ensure that all users are aware of the issue, and a recall response form to be completed and returned. Customers are to call Terumo CVS Customer Service to obtain a Return Goods Authorization number. The letter also included MedWatch reporting information and stated that Customers with questions should call 1-800-521-2818.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution -- USA, Belgium, Australia, Mexico, and Japan.

Official Source

View FDA Recall →

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

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