Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner C
FDA device recall Z-1357-2023 · posted 2023-04-19 · Open, Classified
Recall details
- Recalling firm
- Covidien
- 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.
- Action taken
- 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.
- Root cause
- Component change control
- Status
- Open, Classified
- Product code
- JOH
- Quantity affected
- 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
- Date initiated
- 2023-03-24
- Date posted
- 2023-04-19
- Location
- Boulder, CO
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