Recall Z-1802-2018— Bard Peripheral Vascular Inc

Name: FDA recall Z-1802-2018
Creator: U.S. Food and Drug Administration
Published: 2018-04-16

Class II · Terminated

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2018-04-16, terminated 2021-03-02. It names one FDA 510(k) clearance: K103367. 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.. 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..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Terminated
Initiated: 2018-04-16
Terminated: 2021-03-02
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K103367 — SEEKER CROSSING SUPPORT CATHETERBard Peripheral Vascular, Inc.·cleared 2010-12-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.