10
Apr
2013

Class l Animas(R) 2020 Insulin Infusion Pump

,
0

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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