COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tu
Summary
The FDA issued a Class II for COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. by Covidien. Reason: Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system..
Details
Source
Device Recall
External ID
Z-1318-2023
Action Date
2023-04-05
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Product Number: 86051 UDI-DI (GTIN) Code: 60884522000241 Lot Numbers: 22G0343JZX 22G0344JZX
Quantity Affected: 12,310 devices
Reason for Recall
Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.
Distribution
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-10
Company
Boulder, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 119 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Covidien has 33 FDA actions in our database, including 17 recalls and 16 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Covidien) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Covidien have FDA actions?
Covidien has 33 FDA actions in our database, including 17 recalls and 16 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1318-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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