Bard PowerPort isp M.R.I. Implantable Port Recalled for Incorrect Sheath Size
Bard Peripheral Vascular Inc is recalling 900 units of PowerPort isp M.R.I. Implantable Ports because they were packaged with the incorrect introducer sheath size.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity recall involving a packaging defect.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 900 units of the PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter. The recall was initiated after the company received complaints that the products were packaged with the incorrect introducer sheath size.
The affected devices are identified by Product Code 1808060, Device Listing Number D004935, and Lot Number RECS2407. The UDI for the recalled units is (01)00801741027031(17)191130(10)RECS2407. The recall is classified as Class II by the U.S. Food and Drug Administration.
The distribution pattern for these units is nationwide in the United States, with no distribution outside the U.S. The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the defect.
The recalled product
- Product
- PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 900
Distribution
Distributed nationwide across the United States.
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