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Recall Observatory FDA recall evidence

Device 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.

Z-1802-2018

April 16, 2018

Class II

Product summary

Firm
Bard Peripheral Vascular Inc
Event
Event 79896
Status
Terminated
Classification
Class II
Quantity
140 units
Official record key
device-enforcement:Z-1802-2018

Official wording

Reason: Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting.

Code information: UDI: (01)00801741067921(17)191115(10)VTBY0563, Lot Number: VTBY0563

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting.