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U.S. Department of Health and Human Services

Class 2 Device Recall Endobronchial Tubes

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 Class 2 Device Recall Endobronchial Tubessee related information
Date Initiated by FirmJuly 31, 2009
Date PostedSeptember 16, 2009
Recall Status1 Terminated 3 on September 15, 2011
Recall NumberZ-1944-2009
Recall Event ID 52823
510(K)NumberK850964 
Product Classification Connector, airway (extension) - Product Code BZA
ProductHudson RICA Sheridan, EB Tube, Sher-I-Bronch, LS, 35FR, Nova Plus, 37FR, 39 FR, and 41 FR, Teleflex Medical, Research Triangle Park, NC 27709. Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes.
Code Information Catalog Number: V5-16035, Lot Numbers: 1140268, 1140907, 1170555, 1178484, 1183448, 1194376, 1201935, 1208297, 1244546, 1275365, 01A0800182, 01D0800258, 01H0800057 and 01H0800402;   Catalog Number: V5-16037, Lot Numbers: 1145385, 1153622, 1158906, 1160679, 1163824, 1176066, 1182302, 1185569, 1190950, 1193074, 1199354, 1236306, 1246651, 1271778, 1278921, 1280706, 01K0700358, 01B0800201, 01C0800187, 01G0800445, 01J0800075 and 01A0900206;   Catalog Number: V5-16039, Lot Numbers: 1133751, 1152985, 1161068, 1164080, 1170555, 1176067, 1184133, 1191586, 1197169, 1198624, 1214179, 1215134, 1234645, 1266007, 166785, 1268697, 1271779, 01B0800049, 01B0800202, 01C0800352, 01G0800444 and 01A0900241; and   Catalog Number: V5-16041, Lot Numbers: 1167165, 1178485, 1197171, 1205970, 01K0700160 and 01K0800041. 
Recalling Firm/
Manufacturer
Teleflex Medical
4024 Stirrup Creek Dr
Durham NC 27703-9000
For Additional Information ContactAngela Brown
919-433-4901
Manufacturer Reason
for Recall
The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs.
FDA Determined
Cause 2
Process control
ActionTeleflex Medical, Inc. notified consignees via overnight mail starting July 31, 2009 requesting acknowledgement of the recall and a request to return all of the affected product. Distributors were instructed to forward the letter to their consignees and retrieve relevant product from those locations. Affected product received by Teleflex Medical will be destroyed or reworked and replacement product or credit will be provided to the consignee. For further information, contact Teleflex Medical at 1-919-433-4986.
Quantity in Commerce569,465 eaches (total for all types)
DistributionU.S. Nationwide, Canada, Mexico, Europe, India, Asia Pacific Rim, South and Latin America. (Including: Malaysia, Hong Kong, Vietnam, Singapore, Thailand, Korea, China, Japan, Philippines, Australia, New Zealand, France, Germany, Ireland, Sweden, Costa Rica, Puerto Rico, Jamaica, Brazil, Argentina, Uruguay and Colombia).
Total Product Life CycleTPLC Device Report

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.
510(K) Database510(K)s with Product Code = BZA
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