Medline bronchoscopy kits with Olympus biopsy valves recalled for rubber fragment detachment risk
Stop using affected Medline bronchoscopy kits immediately
Medline convenience kits containing Olympus biopsy valves may have defective valves that shed rubber fragments during use. These fragments could lodge in a patient's airway, potentially requiring removal and causing inflammation or breathing problems.
- Check your inventory for the three affected kit models: BRONCH PACK (DYKE2096), NON MB BRONCHOSCOPY CCH LH PK (DYNJT6182), and PULMONARY BRONCH PACK (DYNDA2861A)
- Do not use any kits matching the recalled lot numbers listed in the FDA notice
- Contact Medline or Olympus for replacement kits or instructions
- Report any valve defects or patient incidents to the FDA MedWatch program
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1706-2026More Medline Industries, LP recalls
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