Device Recall Sarns Centrifugal Pump

Product Number 164275X, Serial Numbers: KP01, KP15, LA05, LA12, LA19, LC02, LC09, LC23, LD02, LD09, LD16, LD30, LE06, LE08, LE13, LE20, LE27, LE29, LF04 and LF07.

Cardiovascular Devices

2

No

Nationwide Distribution

Sarns Centrifugal Pump (with X-coating), catalog 164275X, packaged in 8 piece shelf boxes, and convenience kits with single pump units. || Indicated as extracorporeal blood pumps for use in cardiopulmonary bypass procedures lasting up to 6-hours.

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

Cardiovascular Devices

2

No

The product was sold to medical device distributors and to direct accounts nationwide and to a subsidiary in Japan.

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.