Power-Trialysis Slim-Cath Dialysis Catheters Recalled by Bard Access Systems
Bard Access Systems is recalling Power-Trialysis Slim-Cath short-term dialysis catheters due to lidocaine ampoules manufactured under deficient manufacturing practices. The recall affects multiple product models distributed nationwide and internationally.
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 2/5 (Moderate).
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: The FDA classified this as a Class II recall. The source text identifies a manufacturing deficiency but does not report any hospitalizations, injuries, or illnesses. This qualifies as a moderate-severity recall under the rubric criteria for Class II recalls without reported adverse health consequences.
Plain-English summary
Bard Access Systems, Inc., is recalling Power-Trialysis Slim-Cath Short-Term Dialysis Catheters in both straight and precurved extension configurations. The devices are intended for short-term vascular access (less than 30 days) for hemodialysis, hemoperfusion, and apheresis treatments, with insertion in the jugular, femoral, or subclavian vein.
The recall is due to lidocaine ampoules being manufactured under deficient manufacturing practices by the manufacturer. Affected lot numbers include REKY2412, REKY1364, RELN0881, REKY1381, and REJZ0927 across five product codes with distinct UDI-DI identifiers.
Distribution includes nationwide U.S. coverage (all states plus Puerto Rico and Washington, D.C.) and Belgium. A total of 915 units were distributed. If you have received or used these catheters, contact Bard Access Systems for guidance on next steps.
The recalled product
- Product
- 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 5855300 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107184 5865120 Power-Trialysis Slim-Cath…
- Manufacturer
- Bard Access Systems, Inc.
- Affected units
- 915
Distribution
Part of a larger recall action
This product is one of 14 recalled by Bard Access Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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