DuoGlide Short-Term Dialysis Catheter recall due to deficient manufacturing
Bard Access Systems is recalling lidocaine ampoules used with DuoGlide Short-Term Dialysis Catheters due to deficient manufacturing practices by the supplier. The catheters are used for temporary vascular access for hemodialysis.
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: FDA Class II recall with no reported illnesses or injuries stated. The hazard is manufacturing deficiency of an accompanying component (lidocaine ampoules), and the source does not indicate reported harm, making this a precautionary recall that warrants Moderate severity.
Plain-English summary
Bard Access Systems, Inc. is recalling lidocaine ampoules due to deficient manufacturing practices by the manufacturer. The lidocaine ampoules are supplied with the DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen (UDI-DI Code: 00801741042119, Lot Number: REKY0255). The catheter is intended for temporary vascular access (less than 30 days) for hemodialysis, hemoperfusion, or apheresis therapy via the jugular, subclavian, or femoral vein.
The affected product has been distributed nationwide across all U.S. states and to Belgium. A total of 310 units were involved in this recall.
Patients and healthcare providers should discontinue use of the recalled lidocaine ampoules. Those with questions about the recall should contact Bard Access Systems, Inc., or consult their healthcare provider.
The recalled product
- Product
- 5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 The intended use of the Short-Term Dialysis Catheter is attaining temporary/short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, or apheresis…
- Manufacturer
- Bard Access Systems, Inc.
- Affected units
- 310
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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