FDA Medical devices recall ·
MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY recall
- Recall number
- Z-0515-2025
- Date
- (initiated October 16, 2024)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2592 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699; 2) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699A
Why was it recalled?
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0515-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.