Medline Anterior Hip Pack recalled for Olympus biopsy valve rubber fragments
What this means
Medline's Anterior Hip Pack surgical kits contain Olympus biopsy valves that may shed rubber fragments. These fragments could lodge in a patient's airway during a procedure, potentially requiring removal and causing breathing problems or inflammation.
- Stop using Medline Anterior Hip Pack DYNJ64672B (Lot 23LMD300) immediately
- Check your facility's inventory for affected kits using UDI-DI 10195327377496 or 40195327377497
- Contact Medline Industries or the FDA for instructions on returning or destroying unused kits
- Review patient records if kits were already used and report any airway complications to your healthcare provider
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-1711-2026More Medline recalls
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