3M Model 3000 & Model 3100 Infusion Pump (Modification)

• 2 recalls, same reason

  • Terminated Z-1605-2008 FDA Unclassified (pre-2012) ·initiated 27 Feb 2008
  • Terminated Z-1604-2008 FDA Unclassified (pre-2012) ·initiated 27 Feb 2008

  The Deltec, Graseby, and 3M, Large Volume Infusion Pump - Models 3000 and 3100, may deliver an unintended bolus if the pump door is opened and then immediately closed. This problem is due to a timing delay when the pumping mechanism resets itself.

510(k) Number

K940446 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

ST

• 3M Comply 1248 Gas Plasma Chemical Indicator

  Class II

  FDA 510(k) K013228 Active Cleared 18 Jan 2002

• 3M Comply 1249 Liquid Peracetic Acid Chemical Indicator

  Class II

  FDA 510(k) K000355 Active Cleared 23 Aug 2000

• 3M Red Dot Radiolucent Monitoring Electrode with Conductive Adhesive

  Class II

  FDA 510(k) K000690 Active Cleared 17 May 2000

• 3M Clinpro Prophy Paste, Model 12611

  Class I

  FDA 510(k) K990482 Active Cleared 13 May 1999

• 3M Red Dot ECG Lead Wires a

  Class II

  FDA 510(k) K954900 Active Cleared 15 Jul 1996

• 3M Ferlic Chest Filter, X-Ray Compensating Filter

  Not classified

  FDA 510(k) K837117 Active Cleared 9 Mar 1983

See all devices from Minnesota Mining and Mfg. Co. →