Z-1427-2012

Hudson RCI, BiteGard Oral Bite Block, Single Patient Use, Rx Only, Teleflex Medical, Research Triangle Park...

Name: Z-1427-2012 Hudson RCI, BiteGard Oral Bite Block, Single Patient Use, Rx Only, Teleflex Medical, Research Triangle Park...
Creator: Teleflex Medical
Published: 2012-04-03
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2012-04-03 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of Hudson RCI, BiteGard Oral Bite Block, Single Patient Use, Rx Only, Teleflex Medical, Research Triangle Park, NC. The Teleflex Medical BiteGard Molar Bite Black... on 2012-04-03. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1427-2012
Status: Terminated
Initiated: 2012-04-03
Posted: 2012-04-16
Terminated: 2014-05-20
Recalling firm: Teleflex Medical
Product: 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.
Product code: KOG
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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).
Quantity in commerce: 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.
Product codes and lots: Catalog number: 1140; Lot numbers: 02A0800905, 02C1100483, 02F1000054, 02J0902663, 02A0801994, 02C1101954, 02F1000055, 02J1000939, 02A1000256, 02C1102754, 02F1100700, 02J1001824, 02A1000257, 02D0800059, 02F1101638, 02J1001825, 02A1001314, 02D0801329, 02G0801052, 02K0801935, 02A1001766, 02D0900557, 02G0802642, 02K0803847, 02A1100326, 02D0901732, 02G0900707, 02K0803848, 02A1101331, 02D1100098, 02G0901295, 02K0803849, 02A1102273, 02E0800110, 02G0902610, 02K0900029, 02B0900298, 02E0800342, 02G1000387, 02K0901174, 02B1000808, 02E0802363, 02G1000547, 02K1000019, 02B1000809, 02E0900148, 02G1100211, 02K1000520, 02B1001744, 02E0900638, 02H0800052, 02L1000392, 02B1100389, 02E1000111, 02H0800366, 02L1002223, 02B1101712, 02E1001758, 02H0801439, 02M0900100, 02C0800010, 02E1002588, 02H0801440, 02M0900855, 02C0802808, 02E1100223, 02H0900911, 02M0901463, 02C0901197, 02E1101181, 02J0800358, 02M0902072, 02C1001856, 02F0801932, 02J0801231, 02M1000288, 02C1001857, 02F0900762, 02J0900815 and 02M1000824 and Catalog number: 41140 (sold internationally) Lot numbers: 02A1102347, 02C1000226, 02C1003651, 02C1100970, 02D1001954, 02D1002705, 02D1101766, 02E1000107, 02E1100311, 02G0900700, 02J0802603, 02J1001026, 02K0901769, 02K1000616, 02K1001588, 02L0901972 and 02L1000486.

Product code KOG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)