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Terminated

Hudson RCI, BiteGard Oral Bite Block, Single Patient Use, Rx Only, Teleflex Medical, Research Triangle Park, NC. The Teleflex Medical BiteGard Molar Bite Black is a disposable single patient use device that fits between the patients molars to prevent the patient from closing their mouth entirely and from obstructing the Laryngeal Mask Airway (LMA) tube, in the case where one is used.

FDA Recall Z-1427-2012 · Posted 2012-04-16

Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeKOG
Date Initiated2012-04-03
Date Terminated2014-05-20
Product Quantity333,724 units

Reason for Recall

Teleflex Medical received complaints that the bite block can become separated from the handle. If separation occurs, medical intervention may be required to remove the bite block from the patient's trachea or esophagus/GI tract.

Firm Action

Consignees received "Urgent Medical Device Recall Notification" letters on or about 04/03/2011. The letters described the issue and provided recommended actions regarding remaining product and returns. Questions were directed to Customer Service at (866) 804-9881 (US).

Root Cause

Process control

Distribution Pattern

Worldwide Distribution, including Nationwide (USA) and the countries of Canada, Singapore, China, Denmark, Netherlands, India, Australia, Japan and the United Kingdom.

Official Source

View FDA Recall →

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

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