Cl II Animas Vibe Insulin Infusion Pump

Company: Annimas Corp.
Date of Enforcement Report 2/11/2015
Class lI:

PRODUCT

Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature. Recall Number Z-1034-2015

REASON
ICalibration factors in the pump overwritten during a programming step. The force sensor could send a lower signal value to the pump processor, with loss of prime warnings, occlusion alarms and the pump unable to detect a cartridge during the prime sequence. Field action initiated 8/29/2011.

RECALLING FIRM/MANUFACTURER
Animas Corporation, West Chester, PA 9/6/2011. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1235

DISTRIBUTION
No US distribution, Distributors are located in France, Germany, Sweden and United Kingdom.

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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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