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Terminated

Bravo pH Monitoring System Receiver

FDA Recall Z-0633-04 · Posted 2004-07-20

Recalling FirmMedtronic Gastroenterology / Urology
Recall StatusTerminated
Product CodeFGM
Date Initiated2004-02-06
Date Terminated2005-11-21
Product Quantity1468 units

Reason for Recall

The product's rear panel label could smear during use causing the serial number to be unreadible. This has the remote possibility of resulting in patient data from diagnostic tests being mixed-up or attributed to the wrong patient.

Firm Action

Letters dated February 6, 2004 were sent to the consignees. Enclosed with the letter to each consignee were label sticker(s) having the serial numbers of the device(s) purchased by the consignee. The letters instruct consignees to place the enclosed stickers on the devices over the previous back panel labels if the serial number of the label matches the serial number on the device. Special instructions for devices with smeared labels include the return of devices with unreadable serial numbers.

Root Cause

Other

Distribution Pattern

The devices were distributed nationwide in the United States and worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002028BRAVO PH MONITORING SYSTEMEndonetics, Inc. · 2000-09-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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