Covidien Shiley Lo-Pro Tracheal Tube Cuffed Recalled for Potential Inflation System Leaks
Covidien is recalling Shiley Lo-Pro Oral/Nasal Tracheal Tubes due to potential leaks in the inflation system. The affected devices, used during anesthesia and procedures, may not maintain proper airway sealing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a critical airway management device. The potential leak in the inflation system poses a risk of inadequate airway sealing. No illnesses or injuries are mentioned in the source. Classified as High (Score 3) per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Covidien is recalling Shiley Lo-Pro Oral/Nasal Tracheal Tubes (REF 86051, 7.0 mm I.D.) due to potential leaks in the inflation system. This tracheal tube is used for airway management during anesthesia and other short-term procedures. A leak in the inflation system could prevent the cuff from maintaining a proper seal, potentially affecting airway management during procedures.
The recall affects 12,310 devices distributed across multiple states in the U.S. (Alaska, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Maryland, Michigan, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington, and West Virginia) and Canada. The affected devices are identified by Product Number 86051, UDI-DI (GTIN) Code 60884522000241, and Lot Numbers 22G0343JZX and 22G0344JZX.
Healthcare providers and facilities should discontinue use of the recalled lot numbers immediately. Affected facilities should verify their inventory against the identified lot numbers and contact Covidien for information regarding replacement devices.
The recalled product
- Product
- COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for airway management by oral/nasal intubation of the trachea for anesthesia or other short-term procedures.
- Manufacturer
- Covidien
- Hazard
- inflation-system-leak
- airway-compromise
Distribution
Distributed in 25 states:
- AK
- AZ
- CA
- FL
- GA
- IA
- IL
- IN
- KS
- MD
- MI
- MS
- NC
- NE
- NJ
- NY
- OH
- OK
- PA
- SC
- TX
- UT
- VA
- WA
- WV
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