FDAFDA · Food and drugs·Recall number Z-0510-2025
MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20
Published December 4, 2024 · Recall initiated: October 16, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands
- Lot
- Codes: 1) EPICATH19, UDI/DI 10889942358311(each) 40889942358312(case), Lot Numbers: 22FBX111, 22FBY472, 23FBT886, 23GBL403, 23GBO700, 23GBO701, 23GBO702; 2) EPICATH20, UDI-DI: 10889942358328 (each) 40889942358329 (case), Lot Numbers: 22FBN457, 22HBM699, 22HBN345, 23CBF321, 23DBM670, 23FBK248, 23GBO703, 23GBO704 23GBO705, 23KBG553, 23KBS111
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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