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U.S. Department of Health and Human Services

Class 1 Device Recall Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula

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 Class 1 Device Recall Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannulasee related information
Date Initiated by FirmFebruary 26, 2025
Date PostedMarch 25, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1390-2025
Recall Event ID 96371
510(K)NumberK150844 
Product Classification Tube tracheostomy and tube cuff - Product Code JOH
ProductShiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Code Information UDI-DI/GTIN: A8845212054401, 20884521205441, 10884521205444. Lot: 202405258X. Expiration: 06/01/2029
Recalling Firm/
Manufacturer		 Covidien
6135 Gunbarrel Ave
Boulder CO 80301-3214
For Additional Information ContactTechnical Support
800-255-6774
Manufacturer Reason
for Recall		Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 2/26/2025, recall notices were mailed and/or emailed to Risk Managers, Directors of Respiratory Care, Anesthesiology, Pulmonary/Intensive Care and ENT who were asked to do the following: 1) For patients with affected devices currently in place, a replacement is required. The patient's medical team should assess the overall patient risk when considering the timing of replacement. Clinicians should continue to follow current product Instructions For Use (IFU) along with facility specific policies and procedures. 2) Quarantine and return all unused product from the affected lot in your inventory to the firm. 3) Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product from the specified lot has been transferred or distributed. 4) Complete and return the enclosed Customer Confirmation Form via email to rs.gmbmitgfca@medtronic.com If you have any questions regarding this communication, contact the firm's Customer Service at 800-962-9888, Option 2.
Quantity in Commerce780
DistributionOUS: France, Germany, Ireland, Italy, Lithuania, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Taiwan
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JOH
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