Apr

2012

Cl ll OneTouch(R) Ping(R) Insulin Pump

Company:Animas Corp
Date of Enforcement Report 4/18/12
Class ll:

PRODUCT
OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy. Part number 101420-00, 10142100, 101422-00, 101424-00, 101425-00, 100430-00, 100431-00, 100432-00, 100434-00, 100435-00, 101420-98, 101421-98, 101422-98, 101424-98, 101425-98, and 10050000. Recall # Z-1376-2012

REASON
There is an error in the pump software where the OneTouch(R) Ping(R) insulin pump did not allow the user to save changes to the time and date on the pump if those changes were made on February 29, 2012 (Leap Day). Users who did not attempt to change the time or date on their pump on February 29, 2012 are not affected by this issue.

RECALLING FIRM/MANUFACTURER
Animas Corp., West Chester, PA, by letters dated March 6, 2012. Firm initiated recall is ongoing.

DISTRIBUTION
Nationwide, Canada and Puerto Rico

About the author

Amy Sellers

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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Cl ll OneTouch(R) Ping(R) Insulin Pump

Amy Sellers

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