Bard Access Systems Recalls PowerLoc MAX Safety Winged Infusion Set
Bard Access Systems is recalling 700 units of the PowerLoc MAX Safety Winged Infusion Set due to a potential incorrect Maximum Flow rate label on the packaging.
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, but the source text identifies the issue as a potential incorrect label on the packaging rather than a structural defect or reported injury. This aligns with the rubric for moderate severity involving labeling errors or precautionary actions without reported harm.
Plain-English summary
Bard Access Systems is conducting a field action for the PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215. The recall involves 700 units from Lot D430107 that were distributed to Georgia and Minnesota. The device is intended for the administration of fluids and drugs, blood sampling, and power injection of contrast media through surgically implanted vascular ports.
The field action is being conducted because an incorrect Maximum Flow rate label associated with the power injection Instructions for Use (IFU) may have been attached to the outside of the unit pouch. This labeling error could potentially affect the accuracy of the flow rate information provided to users.
Healthcare providers and facilities that have received these specific units should stop using them and contact Bard Access Systems for further instructions. The recall is limited to the specific lot and product code identified in the notice.
The recalled product
- Product
- PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. The PowerLoc MAX SWIS is also…
- Manufacturer
- Bard Access Systems
- Category
- Medical Device — Infusion Set
- Hazard
- Affected units
- 700
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 (1)
- Lot D430107
Distribution
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