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U.S. Department of Health and Human Services

Class 2 Device Recall Sheridan/CF Cuffed Tracheal Tube

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 Class 2 Device Recall Sheridan/CF Cuffed Tracheal Tubesee related information
Date Initiated by FirmNovember 12, 2014
Date PostedDecember 12, 2014
Recall Status1 Terminated 3 on October 13, 2017
Recall NumberZ-0799-2015
Recall Event ID 69758
510(K)NumberK822082 
Product Classification Tube, tracheal (w/wo connector) - Product Code BTR
ProductSheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. Designed for oral and nasal intubation and are indicated for airway management.
Code Information Product Code: 5-10116, Lot number: 01A1400211
FEI Number 3005747797
Recalling Firm/
Manufacturer		 Teleflex Medical
4024 Stirrup Creek Dr
Durham NC 27703-9000
For Additional Information ContactTara Torres
919-433-4829
Manufacturer Reason
for Recall		Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5mm tracheal tube.
FDA Determined
Cause 2		Process control
ActionConsignees were notified by an Urgent Medical Device Recall Notification letter on 11/12/2014. The letter identified the affected product, as well as, the reason for the recall. Customers are instructed to immediately discontinue use of and quarantine any affected product. They are also instructed to complete and fax or e-mail the enclosed Recall Acknowledgement Form regardless of whether they have affected product in stock or not. Upon receipt of the form, a customer service representative will contact customers to provide an RGA number, as well as, instructions for the return of the product. A local sales representative or customer service should be contacted with questions at 1-866-246-6990.
Quantity in Commerce14,000 units
DistributionWorldwide Distribution -- U.S., Belgium, Canada, and Japan.
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 = BTR
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