Bard PowerPort duo MRI Implantable Port Recalled for Catheter Function Issues
Bard Peripheral Vascular Inc is recalling 189 units of PowerPort duo MRI Implantable Ports due to potential catheter flushing difficulties and septum dislodgement.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall is classified as FDA Class II. The hazard involves potential device malfunction (flushing/infusion difficulties and septum dislodgement) which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 189 units of the PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter (REF 1829570). The recall covers specific lot codes REEW1060, REEX0568, and REEZ1841. These devices are used for the infusion of medications, IV fluids, parenteral nutrition solutions, and blood products, as well as for the withdrawal of blood samples.
The recall was initiated because the catheters may experience difficulty in flushing, infusion, and/or aspiration, and the septum may dislodge. The affected units were distributed nationwide in the United States, including states such as Alabama, Arizona, California, Florida, New York, and Texas.
Healthcare providers and patients should contact Bard Peripheral Vascular Inc for further instructions on how to manage the recalled devices. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 00801741027192 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood…
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 189
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 (3)
- Code: REEW1060
- REEX0568
- REEZ1841
Distribution
Part of a larger recall action
This product is one of 3 recalled by Bard Peripheral Vascular Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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