The Recall Desk
ModerateFDA (Devices)·Z-2658-2026·Announced 2026-07-08

PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen Medical Device Recall

Bard Access Systems, Inc. is recalling PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen devices due to lidocaine ampoules manufactured under deficient manufacturing practices by the supplier.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with a manufacturing-practices deficiency in a supplied component (lidocaine ampoules). The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is manufacturing-based rather than an identified patient risk.

Plain-English summary

Bard Access Systems, Inc. is recalling the PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen (Model CK000662, UDI-DI Code: 00801741129674, Lot Number: REKT1554). The recall was initiated because lidocaine ampoules supplied with these catheters were manufactured under deficient manufacturing practices.

Approximately 66 units were distributed nationwide across the United States, including all 50 states plus Washington D.C., Puerto Rico, and Belgium.

Patients or healthcare providers who have received this product should contact Bard Access Systems, Inc. for instructions on whether their specific unit is affected and what steps should be taken.

The recalled product

Product
CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internal reinforcement to aid in catheter placement.
Manufacturer
Bard Access Systems, Inc.
Category
Medical Device — Catheter
Hazard
  • manufacturing-defect
  • deficient-manufacturing-practices

Distribution

Distributed nationwide across the United States.

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