Hudson RCI, BiteGard Oral Bite Block, Single Patient Use, Rx Only, Teleflex Medical, Research Triangle Park, NC. The Tel
FDA device recall Z-1427-2012 · posted 2012-04-16 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KOG
- Quantity affected
- 333,724 units
- Distribution
- Worldwide Distribution, including Nationwide (USA) and the countries of Canada, Singapore, China, Denmark, Netherlands, India, Australia, Japan and the United Kingdom.
- Date initiated
- 2012-04-03
- Date posted
- 2012-04-16
- Date terminated
- 2014-05-20
- Location
- Research Triangle Park, NC
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