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Shiley recallZ-1318-2023 · Covidien · initiated Feb 10, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Covidien or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

On 02/10/2023, Medtronic issued an "Urgent Medical Device Recall" letter via UPS 2 day delivery to customers informing them of potential cuff leaks from the device inflation system in Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed. Customer are instructed to: 1. Quarantine all unused product from the affected lots of Shiley" Lo-Pro Oral/Nasal Tracheal Tube Cuffed. See attachment A for guidance on identifying potentially affected devices. 2. Return all unused product from the affected lots in their inventory to Medtronic as described on the Customer Confirmation Form. 3. Complete the enclosed Customer Acknowledgment Form even if they do not have unused inventory. 4. Pass on the notice to all those who need to be aware within their organization or to any organization where the potentially affected product from the specified lots has been transferred or distributed. Additional Information for Patient Management: As stated in the Instructions for Use that accompanies each device, each tube s cuff should be tested by inflation prior to use. Use of a device with this potential manufacturing assembly error may result in a delay to treatment while an alternate device is obtained. There are no additional patient management recommendations that should be employed for patients where potentially affected devices are currently in use or were used. These patients should be monitored in accordance with your medical facility s critical care protocols. Clinical staff should appropriately assess and manage patients for any adverse clinical outcomes. For questions or further assistance, contact a Medtronic Representative or Customer Service at 800-962-9888.

Recall details

Recall number
Z-1318-2023
Status
Open, Classified
Initiated by the company
Feb 10, 2023
Posted by the FDA
Apr 1, 2023
Recalling firm
Covidien
Quantity
12,310 devices
Product code
BTR
FDA submissions
K871204
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

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

27 devices cleared under K871204 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page