Bard Access Systems Recalls Power-Trialysis Dialysis Catheters
Bard Access Systems is recalling Power-Trialysis dialysis catheters as a downstream action to a Class I recall.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies this as a downstream recall of a Class I recall. Per the rubric, FDA Class I recalls are never scored below 4.
Plain-English summary
Bard Access Systems, Inc. is recalling Power-Trialysis Short-Term Straight, Curved Extension, Alphacurve, and Slim-Cath dialysis catheters. The recall involves 149,521 units distributed across 49 states, the District of Columbia, and Puerto Rico.
This action is a downstream recall of Class I recall RES 98777. The source text does not specify the exact nature of the defect or the specific health hazards associated with the devices.
Healthcare facilities and distributors should stop using the affected devices and contact Bard Access Systems for further instructions.
The recalled product
- Product
- Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605200; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605240; Power-Trialysis Short-Term Straight Dialysis Catheter, REF…
- Manufacturer
- Bard Access Systems, Inc.
- Hazard
- Affected units
- 149,521
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF/UDI-DI/Lot(Expiration): 5605150/801741086953/ REKQ2236(08/31/2026)
- REKR0948(08/31/2026)
- REKR3422(09/30/2026)
- REKR3433(09/30/2026)
- REKS1563(10/31/2026)
- REKS3564(09/30/2026)
- REKS3559(10/31/2026)
- REKT0573(11/30/2026)
- REKT1722(09/30/2026)
- REKT3057(10/31/2026)
- REKU1678(12/31/2026)
- REKV0926(01/31/2027)
- REKW0664(02/28/2027)
- REKX0410(03/31/2027)
- REKX1755(03/31/2027)
- REKY2464(03/31/2027)
- REKZ2323(05/31/2027)
- RELN2937(06/30/2027)
- 5605200/801741086960/ REKQ3355(8/31/2026
- REKQ3362(8/31/2026)
Distribution
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