Power-Trialysis Dialysis Catheters Recalled Due to Manufacturing Defects
Bard Access Systems is recalling Power-Trialysis Short-Term Dialysis Catheters with triple-lumen design due to lidocaine ampoules manufactured under deficient manufacturing practices. The recall affects approximately 8,795 units 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: This is an FDA Class II recall for dialysis catheters with deficient manufacturing practices in lidocaine ampoules. No illnesses or injuries have been reported in the source text, and the recall is classified as Class II rather than Class I, placing it in the Moderate category per the rubric.
Plain-English summary
Bard Access Systems, Inc. is recalling Power-Trialysis Short-Term Dialysis Catheters, including straight, curved extension, and alphacurve models with 13 Fr triple-lumen configuration. These devices are used 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 has been initiated due to lidocaine ampoules being manufactured under deficient manufacturing practices. Approximately 8,795 units have been distributed nationwide across all U.S. states and Puerto Rico, as well as to Belgium.
Affected product models include catalog numbers 5605150, 5605240, 5605300, 5615120, 5615200, and 5655120, with specific lot numbers REKX1755, REKW0663, REKY2472, REKZ0393, REKQ1130, REKX3745, REKY2418, and REKY2420. Patients and healthcare providers in possession of these catheters should discontinue use and contact Bard Access Systems for instructions on product return or replacement.
The recalled product
- Product
- 5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 5605240 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086977 5605300 Power-Trialysis Short-Term Straight Dialysis…
- Manufacturer
- Bard Access Systems, Inc.
- Affected units
- 8,795
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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