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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 Tubes see related information
Date Initiated by Firm July 31, 2009
Date Posted September 16, 2009
Recall Status1 Terminated 3 on September 15, 2011
Recall Number Z-1943-2009
Recall Event ID 52823
510(K)Number K850964  
Product Classification Connector, airway (extension) - Product Code BZA
Product Hudson RICA¿ Sheridan, Sher-I-Bronch Accessory Pack, 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: 5-16142, Lot Numbers: 1162530, 1167118, 1169739, 1169740, 1190331, 1200165 and 1207348.
Recalling Firm/
Manufacturer		 Teleflex Medical
4024 Stirrup Creek Dr
Durham NC 27703-9000
For Additional Information Contact Angela 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
Action Teleflex 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 Commerce 569,465 (total for all types)
Distribution U.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 Cycle TPLC 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) Database 510(K)s with Product Code = BZA and Original Applicant = SHERIDAN CATHETER CORP.
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