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Terminated

Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; Catalog No. 804113.

FDA Recall Z-2046-2009 · Posted 2009-08-04

Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDTS
Date Initiated2008-02-05
Date Terminated2009-11-01
Product Quantity7079

Reason for Recall

A loose strand of stainless steel left on the device during manufacturing may result in an unretrieved metal fragment remaining in the patient.

Firm Action

Consignees were notified via Urgent - Medical Device Removal letters dated 2/5/08 to cease use of the product. Terumo CVS will contact customers to arrange replacement for the affected product upon receipt of the attached response form. Questions are to be directed to Terumo CVS Customer Service at 1-800-521-2818.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution --- including USA and countries of Belgium, Brazil, Dominican Republic, Germany, Jordan and Latin America.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982891CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDSCalifornia Medical Laboratories, Inc. · 1998-09-30

Official Source

View FDA Recall →

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

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