FDA (Devices) recall action 98793
The FDA (Devices) publishes a recall like this one as 35 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 35 pages.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
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.
The Arrow two-lumen 14 Fr x 20 cm hemodialysis kit is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 1,180 units affected.
Arrow access trays and multilumen PI CVC kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 1,061,069 units affected.
The Arrow Access Tray, REF ASK-04001-MC3, is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 8,265 units affected.
Arrow radial artery, arterial line and hydrophilic catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall.
Arrow Pacing PSI kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 15,915 units are affected.
Arrow radial and arterial catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 310,606 units affected.
Arrow SAC catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall.
Arrow epidural catheter and catheterization kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 1,525,831 units affected.
The Arrow PICC Access Tray, REF ASK-04001-CG1, is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 360 units affected.
Arrow PICC and PICC/Delta kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 37,738 units are affected.