Olympus biopsy valves in Medline Industries, LP thoracic robotic biopsy valve kits are recalled nationwide. The recall covers 14,379 kits distributed across 13 states. Rubber fragments may detach from single-use biopsy valves, creating a risk of a foreign body in the patient’s tracheobronchial tree and possible inflammation or hypoxia. Healthcare providers and patients should stop using the device
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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Kits: Thoracic Robotic biopsy valve kit DYNJ908777B. UDI-DI 10198459269196 (EA) and 40198459269197 (CS). LOTS: 25EBD732, 25GBG733, 25IBQ613, 25JBD457, 25KBT352, 26ABA235, 26ABP735. Distributor/seller: Medline Industries, LP. Nationwide distribution in the US. States: CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX. Price: Unknown.
Kits contain Olympus biopsy valves with rubber fragments that can detach from the valve slit. Detachment can result in a foreign body in the tracheobronchial tree, requiring intervention for removal. Potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
No injuries or incidents have been reported.
1. Stop using the product. 2. Follow recall instructions provided by the manufacturer. 3. Contact Medline Industries, LP or your healthcare provider for instructions. 4. Await further guidance from the supplier and regulatory authorities.
Manufacturer/Distributor: Medline Industries, LP. Regulatory page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1707-2026. Hours: Unknown. Phone: Unknown. Website: Unknown.
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