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U.S. Department of Health and Human Services

Class 3 Device Recall Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube

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  Class 3 Device Recall Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube see related information
Date Initiated by Firm January 14, 2005
Date Posted March 10, 2005
Recall Status1 Terminated 3 on August 19, 2005
Recall Number Z-0582-05
Recall Event ID 30952
510(K)Number K822082  
Product Classification Tube, Tracheal (W/Wo Connector) - Product Code BTR
Product Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube; an Rx, ETO sterilized, single use device inserted into the patient's trachea via the mouth to maintain an open airway; Hudson RCI, Temecula, CA 92589-9020, Manufactured in Mexico, Catalog number (REF) V5-10316 (8.0 mm)
Code Information Catalog number V5-10316, lot 1152181, expiry 10-2009
Recalling Firm/
Manufacturer		 Teleflex Medical
2345 Waukegan Rd
Suite 120
Bannockburn IL 60015
For Additional Information Contact Ms. Julie McDowell
610-948-2836
Manufacturer Reason
for Recall		 Some of the primary labels have the internal diameter (ID) and outer diameter (OD) numbers reversed, i.e. ID 10.9 mm and OD 8.0 mm instead of the actual ID 8.0 and OD 10.9 mm, mislabeling the size of the tracheal tube.
FDA Determined
Cause 2		 Other
Action The direct accounts were notified of the mislabeling by letter dated 1/14/05, sent via Federal Express, Next Business Day Delivery on the same date. The accounts were requested to return their inventories of the affected lot to Teleflex Medical/Hudson RCI, and to subrecall the lot from their customers.
Quantity in Commerce 8,990 units
Distribution Nationwide
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 = BTR and Original Applicant = SHERIDAN CATHETER CORP.
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