Z-0242-2007

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

Name: Z-0242-2007 Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268
Creator: Terumo Cardiovascular Systems Corp
Published: 2006-09-14
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2006-09-14 / Terminated

FDA source

Terumo Cardiovascular Systems Corp began a recall of Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268 on 2006-09-14. The reason FDA records is "The hand crank handle may separate and detach from the unit during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0242-2007
Status: Terminated
Initiated: 2006-09-14
Posted: 2006-12-07
Terminated: 2008-06-19
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268.
Product code: DTW Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Reason for recall: The hand crank handle may separate and detach from the unit during use.
FDA root cause: Other
Action: Consignees were notified via letter dated 9/14/06 and mailed between 9/15/06 and 9/28/06 to check their handle type and to contact Terumo for replacement if they have Boutet-style handles. The recall was extended to additional serial numbers and consignees via additional letter sent on 11/17/06.
Quantity in commerce: 625
Distribution: Worldwide Distribution, USA and Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
Product codes and lots: Serial numbers 1997-2005, 2011-2068, 2070-2077, 2079-2137, 2141-2154, 2156-2241, 2243-2257, 2259, 2260, 2262, 2263, 2265-2274, 2276-2278, 2280, 2282-2310, 2312- 2350, 2353-2365, 2367-2460, 2462-2475, 2477-2485, 2488-2523, 2526-2555, 2558-2583, 2585-2600, 2602, 2606-2621, 2624-2628, 2630-2636, 2638, 2639, 2641-2645, 2647, 2650, 2652-2657 and 2661 through 2668.

Product code DTW

K882758Class IICentrifugal Pump System Lx/dx Version3M Health Care, Sarns / cleared 1988-10-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)