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Recall Observatory FDA recall evidence

Device product

MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF PAIN1622A

Z-0511-2025

October 16, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
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

    reason.no_named_rule · v1.0.0

    The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.