Medline Industries, LP: MEDLINE ANTERIOR HIP PACK DYNJ64672B
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medline Industries, LP
- Product
- MEDLINE ANTERIOR HIP PACK DYNJ64672B
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.
- Recall initiated
- 2026-02-16
- Code info
- UDI-DI 10195327377496 (EA) 40195327377497 (CS) LOT 23LMD300
- Product quantity
- 14,379 kits total
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 98530
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