FOR IMMEDIATE RELEASE Contact: Audrey Finkelstein
1 877 YES PUMP
ANIMAS INITIATES VOLUNTARY RECALL FOR MARCH PUMPS
FRAZER, PA (April 4, 2001) - Animas has initiated a voluntary recall on pumps manufactured between March 1 and March 27. During a routine quality audit, the company discovered that a small percentage of pumps manufactured during this period may have a defective vent. Patients with affected pumps have been notified by Animas. There have been no reported incidents of any adverse event associated with this defective vent.
Those insulin pumps with a defective vent can be used safely except when:
This vent allows the air pressure on the inside of the pump to equilibrate with the air pressure on the outside . A pump with a defective vent could deliver an unintentional dose of insulin when the pump experiences a substantial decrease in air pressure.
- traveling in an airplane, or
- traveling at an altitude 3000 feet greater than where the cartridge was inserted
In the interest of patient safety, Animas is initiating this voluntary recall. Customers are welcome to contact Animas at 877-937-7867 with any questions concerning their insulin infusion pumps.
Last Updated: jueves agosto 29, 2002 20:59:48
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