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.