Medline Industries, LP recalled 14,379 anterior hip pack kits distributed nationwide after Olympus biopsy valves showed rubber fragment detachment. The defect can release fragments into the patient’s airway, risking a foreign body in the tracheobronchial tree and prolonging procedures. Stop using the kit and follow recall instructions from Medline and your healthcare provider.
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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The Medline anterior hip pack kit is a surgical supply used in hip arthroscopy procedures. It contains disposable biopsy valves supplied by Olympus.
Rubber fragments detaching from single-use Olympus biopsy valves can become a foreign body in the airway, potentially requiring removal and causing inflammation or hypoxia.
This recall is not presented as part of a broader industry pattern in the provided data.
Hospitals and providers must halt use immediately, manage patient safety risk, and coordinate with Medline for refunds or replacements.
Packaging and accompanying recall notices; FDA recall page and Medline instructions
Refunds or replacements typically take several weeks after submission of a claim, depending on Medline’s processing schedule
Keep copies of recall notices, purchase records, correspondence with Medline, and any incident reports.
Model numbers/lot codes: UDI-DI 10195327377496 (EA); 40195327377497 (CS); Lot 23LMD300. Distribution: US nationwide. Sold to healthcare facilities. When sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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Medline Industries, LP recalled 14,379 kits nationwide that include Olympus biopsy valves. The recall concerns rubber fragments detaching in the slit of single-use biopsy valves. Stop using these kits immediately and follow manufacturer instructions for return or replacement.
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