Bard Peripheral Vascular Seeker Crossing Support Catheter Recalled for Endotoxin Risk
Bard Peripheral Vascular Inc is recalling 130 units of Seeker Crossing Support Catheters due to potential bacterial endotoxin on packaging hoops, posing a cross-contamination risk.
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 involves a high-risk pathogen (bacterial endotoxin) with a potential for cross-contamination in a clinical setting, but no illnesses or injuries have been reported, fitting the criteria for a High severity score.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 130 units of the BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014. The device is intended to support a guidewire during access into the vasculature. The recall affects Lot Number VTBZ0193, which was distributed nationwide.
The recall is issued because the device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop. While the bacterial endotoxin levels on the catheters themselves are within acceptable limits, the presence of endotoxin on the packaging hoops may have the potential for cross-contamination in a clinical setting.
Healthcare facilities and distributors should stop using the affected units and contact the recalling firm for instructions on return or disposal. This recall is classified as Class II by the FDA.
The recalled product
- Product
- BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014. Intended to support a guidewire during access into the vasculature.
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 130
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)00801741067907(17)191207(10)VTBZ0193
- Lot Number: VTBZ0193
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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