Recall Z-1551-2021— Bard Peripheral Vascular Inc

Name: FDA recall Z-1551-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-25

Class II · Terminated

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2021-03-25, terminated 2023-04-10. It names one FDA 510(k) clearance: K090512. Product: PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 00801741027192 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.. Reason: Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Terminated
Initiated: 2021-03-25
Terminated: 2023-04-10
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K090512 — POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETERC.R. Bard, Inc.·cleared 2009-03-27

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 duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 00801741027192 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

Reason for recall

Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.

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