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Recall Observatory FDA recall evidence

Device 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.

Z-1318-2023

February 10, 2023

Class II

Product summary

Firm
Covidien
Event
Event 91841
Status
Ongoing
Classification
Class II
Quantity
12,310 devices
Official record key
device-enforcement:Z-1318-2023

Official wording

Reason: Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.

Code information: Product Number: 86051 UDI-DI (GTIN) Code: 60884522000241 Lot Numbers: 22G0343JZX 22G0344JZX

Distribution pattern: U.S.: AK, AZ, CA, FL, GA, IA, IL, IN, KS MD, MI, MS, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, WA, and WV O.U.S.: Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.