McGaw Stratus Infusion pumps 28 units. Class II

McGaw Stratus Ambulatory Infusion System Model 550 and Alphamed EZ Pump, Model 550 withSoftware Version 2.32.00/2.42.01. Recall #Z-188-9.

REASON

The pump could under infuse or blood could back up into IV lines when the pumps are running at a slow
flow rate with a large infusion set.

CODE

Serial Numbers: P61145, P71108, P71115, P71125, P71130, P71135, P71142, P71147, P71152, P71157,
P71162, P71166, P71167, P71168, P71173, P71183, P71185, P71192, P71194, P71195, P71201,
P71202, P71205, P71208, P71210, P71211, P71216, P71225, P71233, P71234, P71243, P71244,
P71259, P71266, P71283, P71319, P71607, P71616, P71620, P71621, P71626, P71647, P71649,
P71652.

MANUFACTURER

Alphamed, Inc., Norcross, Georgia.

RECALLED BY

Manufacturer, by returning product around June 1997. Firm-initiated recall complete.

DISTRIBUTION

Texas.

QUANTITY

28 pumps with software version 2.32.00/2.42.01 were distributed.