Medline Industries is recalling 14,379 bronchoscopy kits containing Olympus biopsy valves distributed nationwide in the United States. Olympus reports rubber fragments detaching from the valve slit, which could leave a foreign body in a patient’s tracheobronchial tree and may require removal. Hospitals should stop using the affected kits immediately and follow Medline’s recall instructions.
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 contain Olympus biopsy valves across 13 kit types. 1) BRONCH PROCEDURE KIT, DYKE2091. 2) BRONCHSCOPY, DYNJ900898G and DYNJ901922I. 3) BRONCHSCOPY PACK, DYNJ38313B. 4) BRONCHOSCOPY PACK 0120367-LF, DYNJ32750G and DYNJ32750I. 5) KIT, WR THORACIC, DYNJ911252. 6) LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146B. 7) LEX THORACIC, DYNJ902016K and DYNJ902016L. 8) ORGAN PROCUREMENT, DYNJ908686. 9) PULMONARY PACK, DYKE1859. 10) THORACIC, DYNJ901666L. 11) THORACIC ROBOTICS, DYNJ908777A. 12) THORACOTOMY/THORACOSCOPY, DYNJ900482N and DYNJ900482O. 13) XPS, DYNJ907605. Distribution: US nationwide in CA, FL,,
Kits contain recalled Olympus biopsy valves. Rubber fragments detached from the slit of single-use biopsy valves may detach during use. A fragment could enter the patient’s tracheobronchial tree and require removal. Other potential outcomes include inflammatory response, hypoxia and longer procedures.
No injuries or incidents have been reported.
1. Stop using the product. 2. Follow the recall instructions provided by Medline. 3. Contact Medline Industries, LP or your healthcare provider for instructions. 4. Document kit details and discontinue use as directed. 5. Seek refund or replacement per recall instructions.
Phone: Unknown. Website: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1710-2026. Hours: Unknown.
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