FDA (Devices) recall action 95615
The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medline recalls 1,975 NEXUS catheter connectors that may not fully open, preventing proper catheter insertion. Affected units were distributed nationwide and internationally.
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.
MEDLINE is recalling 3,744 epidural and spinal procedure kits due to a connector defect that may prevent proper catheter insertion. Affected kits were distributed nationwide and internationally.
Medline is recalling over 5,900 epidural catheter kits because the connectors may not open fully, preventing proper catheter insertion. The recall affects units distributed nationwide and internationally.
Medline Industries is recalling procedure kits with connectors that may fail to open fully, preventing proper catheter insertion. The recall affects 3,396 units distributed in the U.S. and internationally.
Multiple MEDLINE procedure kits used for epidural and spinal anesthesia have connectors that may not open fully, preventing proper catheter insertion during medical procedures.
MEDLINE procedure kits are being recalled because connectors may not allow proper catheter insertion if not fully opened. The recall affects 3006 units distributed in the US and internationally.
MEDLINE has recalled 360 units of its Neuraxial Kit (Lot 23KLA330) because connectors may not fully open, potentially preventing catheters from being inserted as intended. Healthcare facilities should discontinue use and contact MEDLINE.