Z-0515-2025 Class II Ongoing
FDA device recall Z-0515-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on October 16, 2024 and is designated Class II. Reason for recall: The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. The recall status is ongoing. Affected quantity: 2592 units.
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
- 2592 units
Product Description
MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699; 2) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699A
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) PAIN1699 UDI-DI: 10193489471908 (each) 40193489471909 (case), Lot Numbers: 22FLB063, 23BLB103, 23CLA768; 2) PAIN1699A UDI-DI: 10195327411107 (each) 40195327411108 (case), Lot Numbers: 23GLA369, 23ILA137