FDAFDA · Food and drugs·Recall number Z-0511-2025
MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF PAIN1622A
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) DYNJRA9043S, UDI/DI 10193489888287(each) 40193489888288(case), Lot Numbers: 23CBE390, 23CBO216, 23EBM309, 23EBP979, 23EBS281, 23GBV099, 23HBG915, 23IBG610, 23IBG611, 23JBQ712, 23KBC341; 2) PAIN1622A, UDI/DI 10193489891690 (each) 40193489891691 (case), Lot Numbers: 21ELA821, 21GLA615, 21KLA308, 22ALA608, 22CLA681, 22ELB088, 22FLB075, 22GLA543, 22KLA019, 23BLA333, 23DLA466, 23HLA896
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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