Bard Peripheral Vascular Seeker Crossing Support Catheter Recalled for Endotoxin Risk
Bard Peripheral Vascular Inc is recalling 140 units of the Seeker Crossing Support Catheter due to potential bacterial endotoxin on packaging hoops.
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 hazard is described as a potential for cross-contamination without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 140 units of the BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. The device is intended to support a guidewire during access into the vasculature.
The recall is due to the risk of detectable levels of bacterial endotoxin present on the packaging hoop used for the catheter. While the endotoxin levels on the catheters themselves are within acceptable limits, the presence of endotoxin on the packaging hoops may pose a potential for cross-contamination in a clinical setting.
The affected units were distributed nationwide. Healthcare providers and facilities should stop using the recalled product and contact the manufacturer for further instructions.
The recalled product
- Product
- BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. Intended to support a guidewire during access into the vasculature.
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 140
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 (2)
- UDI: (01)00801741067921(17)191115(10)VTBY0563
- Lot Number: VTBY0563
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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