Class l Animas(R) 2020 Insulin Infusion Pump

Company:Animas Corporation
Date of Enforcement Report 4/10/2013
Class l:

PRODUCT

Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes. Recall Number Z-0993-2013

REASON
Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following: – Loss of prime; -Occlusion; or -No cartridge detected.

RECALLING FIRM/MANUFACTURER
Animas Corporatio., West Chester, PA, on 1/32013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
7,157 (494 US pumps affected)

DISTRIBUTION
Nationwide and Internationally

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