SARNS INTRACARDIAC SUCKER, BULK, NON-STERILE

FDA device recall Z-0054-2012 · posted 2011-10-17 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

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.

Action taken

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

Status

Terminated

Product code

DTS

Quantity affected

5700

Distribution

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

Date initiated

2011-09-13

Date posted

2011-10-17

Date terminated

2012-12-10

Location

Ann Arbor, MI