Devices

Device Recall Sarns Centrifugal Pump with XCoating

Model / Serial
Pump manufacturing lots: MA04 MA11 MA18 MA25 MC01 MC08 MC15 MC22 MD01 LM12 LM19 LN30 LN23 LP21 LM05 MD22 LP14A LP14 LP14AR MA04R LF04A LM26A LN02A MD29 ME05 MA11R MD15 LE13R LF04R LF11R LF18R LM26T LN02T LN09T LN16T LN23T LN30T LP07T LP14T LP21T MA04T MA11T MA11TA MA18A MA18R MA18T MA18TR MA25R MA25T MA25TA MC01T MC08T MC15T MC22T MD08 MD08T MD22T ME12 ME12T ME19 ME19T
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
The product was sold to medical device distributors and to direct accounts nationwide and to a subsidiary in Japan.
Product Description
Sarns Centrifugal Pump with X-Coating, packaged within custom ordered Cardiovascular Procedure Kits, P/N 3ZZ164275X, 3ZZ164275, CEOT028, CEOT032; and as single sterile units with product codes CV-164275, 164275 and 164275X. || CV-164275 is an item number for product that is sold to foreign affiliate. || Usage: The Sarns Centrifugal Pump (with X-Coating) is indicated as an extracorporeal blood pump for use in cardiopulmonary bypass procedures.
Manufacturer
Terumo Cardiovascular Corporation
1 Event
- Recall of Device Recall Sarns Centrifugal Pump with XCoating

Manufacturer

Terumo Cardiovascular Corporation

Manufacturer Address
Terumo Cardiovascular Corporation, 125 Blue Ball Road, Elkton MD 21921-5315
Manufacturer Parent Company (2017)
Terumo Corp.
Source
USFDA

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