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Terminated

Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268.

FDA Recall Z-0617-2007 · Posted 2007-03-14

Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeKFM
Date Initiated2006-12-12
Date Terminated2008-06-19
Product Quantity2696

Reason for Recall

Internal friction may cause the centrifugal manual drive to be inoperable when a disposable pump is attached.

Firm Action

Consignees will be notified via letter dated 12/12/06, which provides instructions for identifying defective manual drives and to contact the firm if their unit is defective.

Root Cause

Other

Distribution Pattern

Woldwide, including USA, Canada, and Mexico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K882758CENTRIFUGAL PUMP SYSTEM LX/DX VERSION3M Health Care, Sarns · 1988-10-13

Official Source

View FDA Recall →

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

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