Imed 4100 and 4200 Disposable Infusion Device

• • Terminated Z-1170-2009 FDA Unclassified (pre-2012) ·initiated 19 Dec 2008

  The recall was initiated as a result of a potential for out of specification flow rates. The product may not consistently meet the labeled flow rate range of +/- 15%.

510(k) Number

K895797 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• The Imed Ambulatory Infusion Pump, Administration Sets

  Class II

  FDA 510(k) K953896 Active Cleared 20 Mar 1996

• Macrodot Add-I-Med Admin. Set

  Class II

  FDA 510(k) K823347 Active Cleared 24 Nov 1982

• Imed Gemini 12 Nonvented Y-Type Blood/Solution Adm

  Class II

  FDA 510(k) K894842 Active Cleared 12 Sep 1989

• Imed(R) Gemini(Tm) Pc-1 Volumetric Infusion Pump

  Class II

  FDA 510(k) K880479 Active Cleared 25 Apr 1988

• IV Filterset 5 Micrometer

  Class II

  FDA 510(k) K813445 Active Cleared 5 Jan 1982

• Imed Accuset Cassette

  Class II

  FDA 510(k) K812035 Active Cleared 28 Jul 1981

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