Airway exam kits contain recalled Olympus biopsy valves shedding fragments
Medline is recalling the Airway Exam Kit because it contains recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: fragments may lodge in a patient's airway and require removal, and no injuries are stated in the source.
Plain-English summary
Medline Industries, LP is recalling the Airway Exam Kit, DYKE1796. About 14,379 kits were distributed across thirteen US states. The FDA has classified this recall as Class II.
The kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences of fragment detachment include a foreign body in the patient's tracheobronchial tree, which may require intervention for removal, along with inflammatory response, hypoxia and prolongation of the procedure.
Affected product is identified by the kit code above.
Facilities can identify affected kits by the SKU, and may contact Medline Industries, LP for further information.
The recalled product
- Product
- Airway Exam Kit, DYKE1796
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Endoscopy
- Hazard
- fragment-detachment
- foreign-body-risk
- airway-risk
Distribution
Distributed nationwide across the United States.
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