Medline Industries, LP recalled 14,379 Airway Exam Kits containing Olympus biopsy valves nationwide. The recall cites rubber fragments detaching from the slit of single-use biopsy valves. Potential harm includes a foreign body in the patient’s tracheobronchial tree, inflammatory response, hypoxia, and longer procedures. Providers and patients should stop using the kit and follow recall directions.
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 associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions
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Model numbers: Airway Exam Kit DYKE1796. UDI-DI 10193489874716 (ea) 40193489874717 (case). Lot numbers: 24CBT023, 24FBB701, 24LBL343, 25GBP141. Sold nationwide in the United States in states CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX. Sold by Medline Industries, LP. Sold date and price not disclosed.
Kits contain recalled Olympus biopsy valves. Rubber fragments may detach from the valve slit during use. Detached fragments could become a foreign body in the patient’s tracheobronchial tree. This can require removal, cause inflammatory response, hypoxia, and prolong procedures.
No injuries or incidents have been reported.
1. Stop using the product immediately. 2. Follow the recall instructions from the manufacturer and distributor. 3. Contact Medline Industries, LP or your healthcare provider for instructions. 4. Do not attempt to modify or repair the valves. 5. Refer to the recall notice for return or replacement options.
FDA enforcement page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1705-2026. Manufacturer/distributor: Medline Industries, LP. For instructions and potential remedy, contact your healthcare provider or Medline.
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