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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 30
Distribution
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