• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Recall of Level 1 H-31B Air Detector/Clamping Devices, Level 1 H-1200 Fast Flow Fluid Warmers-Smiths Medical ASD, Inc

DATE RECALL INITIATED:

June 20, 2005

PRODUCTS / SERIAL NUMBERS:

Level 1 H-31B Air Detector / Clamping Devices
Level 1 H-1200 Fast Flow Fluid Warmers (with integrated H-31B Air Detector/Clamp)

(See attached list of affected Serial Numbers)

MANUFACTURER:

Smiths Medical ASD, Inc.
Rockland, MA

REASON:

Smiths Medical has received complaints for the Level 1 H-31B Air Detector/Clamping Device and Level 1 H-1200 Fast Flow Fluid Warmers with integrated H-31B Air Detector/Clamp. The Air Detector’s clamping mechanism may not close completely on the IV administration set and/or may have sensitive door/tubing secondary alarm interlocks. There is a possibility the fluid flow will not be stopped if air is detected, which could possibly lead to infusion of air into the patient. There is also a potential for a delay in therapy if the secondary alarm is overly sensitive.

Consignees have been asked to contact the manufacturer to arrange for return of unit(s) for service.

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002