Terumo Cardiovascular Systems Corp Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268.
Brand
Terumo Cardiovascular Systems Corp
Lot Codes / Batch Numbers
Serial numbers 0001 through 2696.
Products Sold
Serial numbers 0001 through 2696.
Terumo Cardiovascular Systems Corp is recalling Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268. due to Internal friction may cause the centrifugal manual drive to be inoperable when a disposable pump is attached.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Internal friction may cause the centrifugal manual drive to be inoperable when a disposable pump is attached.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026