Meter Remote for OneTouch Ping Glucose Management System
FDA Recall Z-0955-2009 · Posted 2009-03-03
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Recalling FirmAnimas Corporation
Recall StatusTerminated
Product CodeLZG
Date Initiated2008-10-27
Date Terminated2009-12-15
Product Quantity5093 units
Reason for Recall
incorrect dosing recommendation
Firm Action
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
Distribution Pattern
Nationwide Distribution --- including states of KY, UT, FL, OH, MA, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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