Cardiovascular Procedure Kit, P/N 70579-04, St. Louis University Hospital Pump & Table Pack, Terumo Cardiovascular, Ashland, MA. (the Pump & Table pack contains a weighted flexible sucker, Catalog No. 804113)
FDA Recall Z-1313-2008 · Posted 2008-03-28
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Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeOEZ
Date Initiated2008-01-29
Date Terminated2009-07-07
Product Quantity252
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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