Medline Industries, LP: Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model Number: DYNJ62849B
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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 Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model Number: DYNJ62849B
- Reason / hazard
- The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2026-02-25
- Code info
- 1) DYNJ48399C, UDI-DI: 10195327172626(each), 40195327172627(case), Lot Number: 24CBU779; 2) DYNJ62849B, UDI-DI: 10195327514884(each), 40195327514885(case), Lot Number: 24BBS275
- Product quantity
- 89 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 98599
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