Medline Industries is recalling 14,379 kits nationwide that include Olympus biopsy valves. The recall follows reports of rubber fragments detaching from the valves during use. Healthcare providers and patients should stop using the affected kits 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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Model numbers included in the recall: DYNJ900898I and DYNJ901922G; DYKM1417I and DYKM1417J; DYNJ58146A; DYNDA2138A. Distribution: US nationwide in CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX. Quantity: 14,379 kits total. Classification: Class II.
Kits contain recalled Olympus biopsy valves. Detachment of rubber fragments from the valve slit may create a foreign body in the patient’s tracheobronchial tree, potentially requiring removal. Other possible consequences include inflammatory response, hypoxia, and longer procedure times.
Olympus is investigating an increase in complaints related to rubber fragment detachment in the slit of single-use biopsy valves. No injuries or fatalities are detailed in the recall notice.
1. Stop using the product. 2. Follow recall instructions provided by the manufacturer. 3. Contact Medline Industries, LP or your healthcare provider for instructions.
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1709-2026. Medline contact information is not provided in the recall notice.
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