Sarns 9000 Universal Roller Pump

• 3 recalls, same reason

  • Terminated Z-1004-2007 FDA Unclassified (pre-2012) ·initiated 1 Jul 2004 ·on shared 510(k) K953904
  • Terminated Z-1002-2007 FDA Unclassified (pre-2012) ·initiated 1 Jul 2004 ·on shared 510(k) K953904
  • Terminated Z-1003-2007 FDA Unclassified (pre-2012) ·initiated 1 Jul 2004 ·on shared 510(k) K953904

  Roller Pump: Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or may fail to start/restart resulting in the pump(s) being non-functional.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K953904 ↗

FDA Product Code

DWB

Device Class

Class II

Regulation

21 CFR Part 870.4370

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Model 480cm Infusion Pump, Modification

  Class II

  FDA 510(k) K924869 Active Cleared 17 Jun 1993

• 3M Prevention Fabric Surgical Gown #78XX

  Class II

  FDA 510(k) K930681 Active Cleared 10 Feb 1994

• 3M Precise Brand Internal Surgical Staples

  Class II

  FDA 510(k) K921051 Active Cleared 16 Jul 1992

• 3M Pediatric Laparotomy Sheet #7938/ #7938NS

  Class II

  FDA 510(k) K946024 Active Cleared 8 Feb 1995

• 3M X-Large Sheet #7979/ #7979NS

  Class II

  FDA 510(k) K946025 Active Cleared 2 Feb 1995

• Red Dot 2515 Cardiac Sensor System

  Class I

  FDA 510(k) K924487 Active Cleared 23 Dec 1992

See all devices from 3M Health Care, Ltd. →