FDAFDA · Food and drugs·Recall number Z-2195-2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI4510; b) VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number STCVC01145B; c) VANTEX TRIPLE LUMEN BUNDLE, Model Number STCVC2000;
Published July 26, 2023 · Recall initiated: May 18, 2023
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
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
- Lot
- All lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number CVI4510, UDI/DI (EA) 10653160321194, UDI/DI (CS) 00653160321197; b) Model Number STCVC01145B, UDI/DI (EA) 10653160351924, UDI/DI (CS) 00653160351927; c) Model Number STCVC2000, UDI/DI (EA) 10653160336792, UDI/DI (CS) 00653160336795
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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