Recall Z-0582-2020— Bard Peripheral Vascular Inc

Name: FDA recall Z-0582-2020
Creator: U.S. Food and Drug Administration
Published: 2019-02-14

Class II · Ongoing

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2019-02-14. It names one FDA 510(k) clearance: K063377. Product: PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter. Reason: Complaints received that products packaged with the incorrect introducer sheath size..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Ongoing
Initiated: 2019-02-14
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K063377 — POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETERC.R. Bard, Inc.·cleared 2007-01-25

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

PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter

Reason for recall

Complaints received that products packaged with the incorrect introducer sheath size.

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