Z-0512-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2024
- Initiation Date
- October 16, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3006 units
Product Description
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
Reason for Recall
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Distribution Pattern
US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands
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