PowerPICC SV Catheters recalled due to deficient lidocaine manufacturing
Bard Access Systems is recalling PowerPICC SV Catheters because lidocaine ampoules supplied with the product were manufactured under deficient practices.
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 no reported illnesses or injuries. The source text identifies a manufacturing deficiency without specifying the nature of the hazard or reporting any adverse health consequences, making this a precautionary recall that meets the Moderate severity threshold.
Plain-English summary
Bard Access Systems, Inc. is recalling PowerPICC SV Catheters, including the 4 Fr Dual-Lumen model (code 1274108D, lot REKW2449) and the 3 Fr Single-Lumen model (code 3173108D, lot REKV2227). These catheters are used for short or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
The recall is due to lidocaine ampoules being manufactured under deficient manufacturing practices by the supplier. A total of 624 units have been distributed.
The affected products were distributed nationwide throughout the United States (including Alaska, Hawaii, and Puerto Rico) and to Belgium. Patients currently using these catheters or healthcare providers in possession of recalled units should contact Bard Access Systems, Inc. for further instructions regarding replacement or proper handling.
The recalled product
- Product
- 1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen REKV2227 00801741027536 The PowerPlCC SV catheters are intended for short or long term peripheral access to the central venous system for intravenous th
- Manufacturer
- Bard Access Systems, Inc.
- Affected units
- 624
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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