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U.S. Department of Health and Human Services

Class 1 Device Recall Shiley" Adult Flexible Tracheostomy Tube with TaperGuard" Cuff and Cuffless

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  Class 1 Device Recall Shiley" Adult Flexible Tracheostomy Tube with TaperGuard" Cuff and Cuffless see related information
Date Initiated by Firm March 24, 2023
Date Posted April 19, 2023
Recall Status1 Open3, Classified
Recall Number Z-1357-2023
Recall Event ID 91943
510(K)Number K142296  K150844  
Product Classification Tube tracheostomy and tube cuff - Product Code JOH
Product Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless:
Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description):
10CN10H, 10.0MM SHILEY CUFFED TRACH CAN;
10CN10R, 10.0MM ADT FLEX TRACH W TG CUFF;
10UN10A, 10.0MM UNCUFF TRACH TUBE X1;
10UN10H, 10.0MM SHILEY CUFFLESS TRACH C;
10UN10R, 10.0MM ADT FLEX TRACH CUFFLESS;
4CN65A, 6.5MM TRACH TUBE W TG CUFF X1;
4CN65H, 6.5MM SHILEY CUFFED TRACH CANN;
4CN65R, 6.5MM ADT FLEX TRACH W TG CUFF X1;
4UN65A, 6.5MM UNCUFF TRACH TUBE X1;
4UN65H, 6.5MM SHILEY CUFFLESS TRACH CA;
4UN65R, 6.5MM ADT FLEX TRACH CUFFLESSX1;
5CN70A, 7.0MM TRACH TUBE W TG CUFF X1;
5CN70H, 7.0MM SHILEY CUFFED TRACH CANN;
5CN70R, 7.0MM ADT FLEX TRACH W TG CUFF X1;
5UN70A, 7.0MM UNCUFF TRACH TUBE X1;
5UN70H, 7.0MM SHILEY CUFFLESS TRACH CA;
5UN70R, 7.0MM ADT FLEX TRACH CUFFLESSX1;
6CN75A, 7.5MM TRACH TUBE W TG CUFF X1;
6CN75H, 7.5MM SHILEY CUFFED TRACH CANN;
6CN75R, 7.5MM ADT FLEX TRACH W TG CUFF X1;
6UN75H, 7.5MM SHILEY CUFFLESS TRACH CA;
6UN75R, 7.5MM ADT FLEX TRACH CUFFLESSX1;
7CN80A, 8.0MM TRACH TUBE W TG CUFF X1;
7CN80H, 8.0MM SHILEY CUFFED TRACH CANN;
7CN80R, 8.0MM ADT FLEX TRACH W TG CUFF X1;
7UN80A, 8.0MM UNCUFF TRACH TUBE X1;
7UN80H, 8.0MM SHILEY CUFFLESS TRACH CA;
7UN80R, 8.0MM ADT FLEX TRACH CUFFLESSX1;
8CN85A, 8.5MM TRACH TUBE W TG CUFF X1;
8CN85H, 8.5MM SHILEY CUFFED TRACH CANN;
8CN85R, 8.5MM ADT FLEX TRACH W TG CUFF X1;
8UN85A, 8.5MM UNCUFF TRACH TUBE X1;
8UN85H, 8.5MM SHILEY CUFFLESS TRACH CA;
8UN85R, 8.5MM ADT FLEX TRACH CUFFLESSX1;
9CN90H, 9.0MM SHILEY CUFFED TRACH CANN;
9CN90R, 9.0MM ADT FLEX TRACH W TG CUFF X1;
9UN90H, 9.0MM SHILEY CUFFLESS TRACH CA;
9UN90R, 9.0MM ADT FLEX TRACH CUFFLESSX1
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Recalling Firm/
Manufacturer		 Covidien
6135 Gunbarrel Ave
Boulder CO 80301-3214
For Additional Information Contact Technical Support
800-255-6774 Ext. 4
Manufacturer Reason
for Recall		 A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure connection could lead to respiratory failure, dyspnea, treatment delay, tissue injury, or bleeding.
FDA Determined
Cause 2		 Component change control
Action On 3/24/23, recall notices were mailed to risk managers and directors of respiratory care. Tracheostomy Tubes that do not securely attach or stay attached to caps or accessories should not be used. 1) All affected unused product should be quarantined and returned to the recalling firm. 2) Complete and then return the customer confirmation form to rs.gmbfcamitg@medtronic.com 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 lots has been transferred or distributed. 4) If purchased from a distributor, contact your distributor directly to arrange for the return of the product back to your distributor. Customers with questions can contact Quality Assurance at 800-255-6774, option 4.
Quantity in Commerce 599,187
Distribution Worldwide - US Nationwide distribution including in the states of PR, CA, FL, MN, PA, AZ, IL, TN, OH, MI, GA, KS, HI, MD, AK, NY, NE, IA, OK, VA, ND, MO, NC, SC, KY, OR, IN, WA, TX, WI, CT, MA, WV, CO, VT, NJ, SD, AR, AL, MS, LA, DE, MT, WY, DC, UT, NV, NH, RI, ID, NM, ME and the countries of Algeria, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bolivia, Plurinational State Of Bosnia And Herzegovina, Brazil, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cote D'Ivoire, Cyprus, Czech Republic, Denmark, El Salvador, Estonia, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Jordan, Kosovo, Kuwait, Lebanon, Lithuania, Luxembourg, Macao, Malaysia, Malta, Martinique, Mexico, Namibia, Netherlands, New Caledonia, New Zealand, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Republic Of Tanzania, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, Viet Nam.
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 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) Database 510(K)s with Product Code = JOH and Original Applicant = Covidien
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