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Recall Observatory FDA recall evidence

Device product

MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF PAIN1423A; 2) CONT. 20G EPI MRI COMPATIBLE, REF PAIN1470A; 3) EPIDURAL CATHETERIZATION KIT, REF PAIN1644

Z-0512-2025

October 16, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95615
Status
Ongoing
Classification
Class II
Quantity
3006 units
Official record key
device-enforcement:Z-0512-2025

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) PAIN1423A UDI-DI: 10193489201826 (each) 40193489201827 (case), Lot Numbers: 22GLA530, 23BLA921, 23DLA373, 23GLA522, 23ILA136, 23JLB217, 23KLA008; 2) PAIN1470A UDI-DI: 10193489957365 (each) 40193489957366 (case), Lot Numbers: 21JLA366, 21JLA956, 21LLA271, 22CLA831, 22DLA301, 22DLB149, 22FLA103; 3) PAIN1644 UDI-DI: 10193489331141 (each) 40193489331142 (case), Lot Numbers: 22FLA985, 23CLA104

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.

Field note

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