FDAClass IIJuly 7, 2021

5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire recall

5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer

Why was 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire recalled?

Catheter kits contained the incorrect micro-introducers.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog Number: 3175155 UDI Code: (01)00801741027680 Lot Number: REEU0201

Product
5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
Recalling firm
Bard Access Systems Inc.
Quantity
180 units
Distribution
U.S.: CT, GA, MA, MI, MT, NJ, NV, NY, VA, and WI. O.U.S.: None
Recall date
July 7, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls