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Class 2 Device Recall Hudson RCI |
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Date Initiated by Firm |
April 03, 2012 |
Date Posted |
April 16, 2012 |
Recall Status1 |
Terminated 3 on May 20, 2014 |
Recall Number |
Z-1427-2012 |
Recall Event ID |
61538 |
Product Classification |
Endoscope and/or accessories - Product Code KOG
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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. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Teleflex Medical 2917 Weck Dr. Research Triangle Park NC 27709
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For Additional Information Contact |
Robert Philips 610-378-0131
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Manufacturer 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.
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FDA Determined Cause 2 |
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. |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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