MEDLINE Epidural Procedure Kits: Connector May Prevent Catheter Insertion
MEDLINE epidural trays used for labor anesthesia may have connectors that fail to fully open, preventing proper catheter insertion. The recall affects 2,592 units distributed across the US and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a potential functional defect in a medical device used for critical labor pain management. No illnesses or injuries have been reported in the source text. Per the rubric, this qualifies as High (3) severity for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
MEDLINE INDUSTRIES, LP is recalling 2,592 units of MEDLINE Continuous Epidural Trays (models REF PAIN1699 and REF PAIN1699A), which are procedure kits used to administer epidural anesthesia during labor and delivery.
The connectors in these kits may not fully open, which could prevent epidural catheters from being inserted as intended. This could impact the ability to deliver pain management during childbirth.
The affected kits were distributed nationwide and internationally to Bermuda, Canada, Panama, the United Arab Emirates, and the U.S. Virgin Islands. Specific lot numbers are identified in the FDA recall notice.
The recalled product
- Product
- MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699; 2) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- device-malfunction
- connector-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 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
Distributed nationwide across the United States.
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