Meter Remote for OneTouch Ping Glucose Management System
Recall
- Recall Number
- Z-0955-2009
- Event Number
- 50796
- Firm
- Animas Corporation
- FEI Number
- 3002920072
- Product Code
- LZG
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- October 27, 2008
- Posted
- March 3, 2009
- Terminated
- December 15, 2009
- Address
- 200 Lawrence Dr, West Chester, PA, 19380
Description
Meter Remote for OneTouch Ping Glucose Management System
incorrect dosing recommendation
The recalling firm issued Urgent: Medical Device Correction letters dated 10/27/08 to their customers/user to inform them of the problem. The letter stated that the firm was in the process of correcting the issue and that a new OneTouch Ping Meter-Remote would be provided as soon as one became available. In the interim, customers could still safely use their OneTouch Ping System provided that they use the ezCarb calculator on the meter-remote when it is paired and communicating with the pump. The letter listed guidelines to ensure that the device is properly communicating with the pump. The letter stated that customers should follow the directions in the Owner's Booklet to troubleshoot any communication issues. Questions regarding this letter were to be directed to Animas at 866-423-4087. A patient acknowledgment letter dated November 18, 2008 was also issued. Another Urgent: Medical Device Correction letter, dated November 2008, was issued along with the replacement device. This letter asked customers to download their current meter-remote data, set up their replacement meter-remote, and then return their current meter-remote.
Nationwide Distribution --- including states of KY, UT, FL, OH, MA, and TX.
5093 units