The Recall Desk
HighFDA (Devices)·Z-1994-2021·Announced 2021-07-07

Bard PowerPICC Catheter Kits Recalled for Wrong Guidewire Size

Bard Access Systems is recalling PowerPICC catheter convenience kits with incorrect guidewires. Kits labeled as containing 70 cm guidewires actually contain 50 cm guidewires, which could affect proper catheter placement.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a medical device with a functional component mismatch that poses a risk of harm. The incorrect guidewire sizing could compromise proper catheter placement. No injuries or illnesses have been reported.

Plain-English summary

Bard Access Systems Inc. is recalling PowerPICC 5 Fr IR Convenience Kit Catheters (Catalog Number CK000340B, Lot Number 20BBK658) due to a labeling mismatch. The kits are labeled as containing 70 cm guidewires but actually contain 50 cm guidewires.

The incorrect guidewire size could compromise proper catheter placement and function. Using a guidewire shorter than labeled may result in improper catheter positioning or inability to use the kit as intended.

The recalled kits were distributed nationwide. A total of 30 kits are affected by this FDA Class II recall.

Patients or healthcare providers who have received these kits should not use them. Contact Bard Access Systems Inc. or your healthcare provider for instructions on obtaining replacement kits with the correct guidewires.

The recalled product

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 Dual-Lumen 70cm Guidewire
Manufacturer
Bard Access Systems Inc.
Hazard
  • incorrect-guidewire
  • label-mismatch

Distribution

Distributed nationwide across the United States.