Medline thoracic robot kits recalled for defective Olympus biopsy valves
What this means
Medline's thoracic robot kits contain Olympus biopsy valves that may shed rubber fragments during use. These fragments could lodge in a patient's airway, potentially requiring removal and causing breathing problems or inflammation.
- Check if your kit matches lot numbers 25EBD732, 25GBG733, 25IBQ613, 25JBD457, 25KBT352, 26ABA235, or 26ABP735
- Stop using affected kits immediately
- Contact Medline or Olympus for instructions on replacement or return
- Report any patient injuries to the FDA MedWatch program
The agency's original wording
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-1707-2026More Medline recalls
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