Medline Anterior Hip Pack with defective biopsy valves recalled
Medline is recalling hip surgery kits containing Olympus biopsy valves with a defect that can cause rubber fragments to detach. These fragments pose a risk of lodging in the patient's airway.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of medical devices with a confirmed defect (rubber fragment detachment) and serious potential consequences including airway obstruction and hypoxia, though no illnesses have been reported. The hazard is real, not theoretical.
Plain-English summary
Medline Industries is recalling 14,379 MEDLINE ANTERIOR HIP PACK DYNJ64672B kits nationwide. These surgical kits contain Olympus single-use biopsy valves that exhibit a defect involving rubber fragment detachment from the valve slit.
Olympus has identified an increase in complaints associated with this defect. When rubber fragments detach, they may become foreign bodies in the patient's tracheobronchial tree (the airway), potentially requiring surgical intervention to remove.
Potential consequences include foreign body aspiration, inflammatory response, hypoxia (insufficient oxygen), and prolonged surgical procedures. The recalled kits were distributed nationwide across California, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Montana, New York, Ohio, Pennsylvania, Tennessee, and Texas.
The recalled product
- Product
- MEDLINE ANTERIOR HIP PACK DYNJ64672B
- Manufacturer
- Medline Industries, LP
- Hazard
- foreign-body-aspiration
- fragment-detachment
- hypoxia
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 10195327377496 (EA) 40195327377497 (CS) LOT 23LMD300
Distribution
Distributed nationwide across the United States.
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