FDA (Devices) recall action 84914
The FDA (Devices) publishes a recall like this one as 10 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 10 pages.
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 catheter. This can result in a prolongation of operation.
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.
Bard Peripheral Vascular Inc is recalling 650 Groshong 9.5 Dual-Lumen CV Catheters because they may contain an incorrect tunneler barb tip, potentially prolonging surgical operations.
Bard Peripheral Vascular Inc is recalling BardPort M.R.I. Implantable Ports because they may contain an incorrect catheter tip, potentially prolonging surgical operations.
Bard Peripheral Vascular Inc is recalling 360 BardPort Titanium Implantable Ports because they may contain an incorrect catheter tip, potentially prolonging surgery.
Bard Peripheral Vascular Inc is recalling 296 PowerFlow Implatable Apheresis IV Ports because they may contain an incorrect tunneler tip, potentially prolonging surgical operations.
Bard Peripheral Vascular Inc is recalling 824 PowerPort isp MRI Implantable Ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.
Bard Peripheral Vascular Inc is recalling 598 Vaccess CT Power-Injectable Implantable Ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.
Bard Peripheral Vascular Inc is recalling 878 PowerPort M.R.I. Implantable Port catheters because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.
Bard Peripheral Vascular Inc is recalling 151 BardPort M.R.I. Hard Base Implantable Ports because they may contain an incorrect tunneler barb tip, potentially prolonging surgical operations.
Bard Peripheral Vascular Inc is recalling 225 X-Port isp MRI Implantable Ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.
Bard Peripheral Vascular Inc is recalling 178 PowerPort implantable ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgery.