Bard Access Systems Recalls PowerPort Slim Implantable Ports Due to Labeling Error
Bard Access Systems is recalling 777 PowerPort Slim Implantable Ports because the labels incorrectly state they contain silicone suture plugs, when some units do not.
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 hazard is a labeling discrepancy regarding the presence of silicone suture plugs. The source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity recall involving minor labeling errors or low-risk issues.
Plain-English summary
Bard Access Systems is recalling 777 units of the PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. The affected product codes are 1716000 and 1716070. The recall involves specific lot numbers: REXA1302, REXA1350, and REXB1160.
The recall was initiated due to a labeling discrepancy. The product labels state that the implantable ports contain silicone suture plugs. However, approximately 23% of the units in the affected lots actually contain a PowerPort Slim titanium implantable port without silicone suture plugs.
The affected units were distributed nationwide in the United States, including Washington, Kentucky, Illinois, and Iowa. Patients and healthcare providers should verify the specific lot numbers and product codes of any implanted or stored devices against the recall list. If a device matches the recalled lots, providers should contact Bard Access Systems for further instructions.
The recalled product
- Product
- PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
- Manufacturer
- Bard Access Systems
- Hazard
- Affected units
- 777
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)
- Lot Numbers: REXA1302
- REXA1350
- REXB1160
Distribution
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