FDA recall Z-1803-2018

Bard Peripheral Vascular Inc · Class II · device

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.

Reason for recall

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.

Distribution

Nationwide Distribution

Key facts

Status: Terminated
Initiation date: 2018-04-16
Report date: 2018-05-23
Termination date: 2021-03-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tempe, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1803-2018