Medline Industries, LP: Sterile Radiology Procedure Kits, Model Number DYNDH1491B
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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
- Sterile Radiology Procedure Kits, Model Number DYNDH1491B
- Reason / hazard
- There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the state of MN.
- Recall initiated
- 2026-02-18
- Code info
- UDI-DI: (CS) 40198459071455, (EA) 10198459071454; Lot Number: 25GBB924
- Product quantity
- 420 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 98529
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