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Terminated

Cardiovascular Procedure Kit, P/N 64789-01, Wisconsin Cardiovascular Services Pump and Table Pack, Terumo Cardiovascular, Ashland, MA. (the Pump & table pack contains a weighted flexible sucker, Catalog No. 804113)

FDA Recall Z-1311-2008 · Posted 2008-03-28

Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeOEZ
Date Initiated2008-01-29
Date Terminated2009-07-07
Product Quantity110

Reason for Recall

Loose Flash at tip of Weighted Flexible Sucker: A loose strand of stainless steel left on the device during manufacturing by an outside supplier may result in an unretrieved metal fragment remaining in the patient.

Firm Action

Consignees were notified via recall letter, Urgent Medical Device Removal, dated 1/29/08 via fax or email to cease using the weighted sucker in the packs and to use an alternative sucker until replacement product arrives from Terumo.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide-USA including states of Missouri, Tennessee and Wisconsin-Custom Kits for 3 hospitals.

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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