Meter Remote for OneTouch Ping Glucose Management System
FDA device recall Z-0955-2009 · posted 2009-03-03 · Terminated
Recall details
- Recalling firm
- Animas Corporation
- Reason for recall
- incorrect dosing recommendation
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 5093 units
- Distribution
- Nationwide Distribution --- including states of KY, UT, FL, OH, MA, and TX.
- Date initiated
- 2008-10-27
- Date posted
- 2009-03-03
- Date terminated
- 2009-12-15
- Location
- West Chester, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYMPHONY GLUCOSE MANAGEMENT SYSTEM (K080639) | Animas Corp. | 2008-06-24 |