Device product
MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF PAIN1622A
Z-0511-2025
Product summary
- Event
- Event 95615
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3396 units
- Official record key
device-enforcement:Z-0511-2025
Official wording
Reason: The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Code information: 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
Distribution pattern: US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands
Derived failure modes
-
Unknown
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.