FDAClass IIJuly 7, 2021

5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen recall

5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size…

Why was 5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen recalled?

Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.

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 (REF) Number: CK000340B UDI Code: (01)00801741126697 Lot Number: 20BBK658

Product
5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size…
Recalling firm
Bard Access Systems Inc.
Quantity
30 kits
Distribution
U.S. Nationwide distribution in the state of RI.
Recall date
July 7, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls