Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Recall
- Recall Number
- Z-1390-2025
- Event Number
- 96371
- Firm
- Covidien
- FEI Number
- 2936999
- Product Code
- JOH
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- February 26, 2025
- Posted
- March 25, 2025
- Address
- 6135 Gunbarrel Ave, Boulder, CO, 80301-3214
Description
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
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.
On 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 [email protected] If you have any questions regarding this communication, contact the firm's Customer Service at 800-962-9888, Option 2.
OUS distribution only to countries of: France, Germany, Ireland, Italy, Lithuania, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Taiwan
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