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Class 2 Device Recall Sheridan/CF Cuffed Tracheal Tube |
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Date Initiated by Firm |
November 12, 2014 |
Date Posted |
December 12, 2014 |
Recall Status1 |
Terminated 3 on October 13, 2017 |
Recall Number |
Z-0799-2015 |
Recall Event ID |
69758 |
510(K)Number |
K822082
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Product Classification |
Tube, tracheal (w/wo connector) - Product Code BTR
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Product |
Sheridan/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 |
Recalling Firm/ Manufacturer |
Teleflex Medical 4024 Stirrup Creek Dr Durham NC 27703-9000
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For Additional Information Contact |
Tara Torres 919-433-4829
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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.
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FDA Determined Cause 2 |
Process control |
Action |
Consignees 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 Commerce |
14,000 units |
Distribution |
Worldwide Distribution -- U.S., Belgium, Canada, and Japan. |
Total Product Life Cycle |
TPLC Device Report
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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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510(K) Database |
510(K)s with Product Code = BTR and Original Applicant = SHERIDAN CATHETER CORP.
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