Bard Peripheral Vascular LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP recall — FDA Z-0792-2022
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Overview of recall records associated with Bard Peripheral Vascular Inc., including dates, categories and classifications where available.
Classification mix: Class II: 99, Class I: 1.
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Due to misbranded products shipped to customers.
Due to misbranded products shipped to customers.
Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick.
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.
Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon size is 6mm x 40mm, however included is a 5mm x 40mm balloon. Use of a balloon that has a…
Incorrect Peel-Apart Introducer Sheath in Kit.
Incorrect Peel-Apart Introducer Sheath in Kit.
The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.
Sterility compromised due to packaging pouches that may not be sealed properly
The firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at risk of experiencing a magnetic deficiency, which may result in the magnets…
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr…
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr…
This page summarizes recall records in which the official source identifies Bard Peripheral Vascular Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.