PowerMidline Catheter 4 Fr Dual-Lumen due to deficient manufacturing
Bard Access Systems is recalling PowerMidline Catheter 4 Fr Dual-Lumen catheters because lidocaine ampoules were manufactured under deficient manufacturing 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. The source text does not report any illnesses, injuries, or hospitalizations, only a deficient manufacturing practice issue. Without reported adverse events, this falls under the moderate category for precautionary recalls.
Plain-English summary
Bard Access Systems, Inc. is recalling PowerMidline Catheter 4 Fr Dual-Lumen catheters (model numbers CK000980A, P4254108, and P4254108D with lot numbers REKX0112, REKW0949, and REJZ1337) worldwide. The product is intended for short-term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media.
The recall is due to lidocaine ampoules being manufactured under deficient manufacturing practices. A total of 2,844 units were distributed nationwide across the United States, including all 50 states, the District of Columbia, Puerto Rico, and Belgium.
Patients and healthcare providers should discontinue use of affected units. Patients should consult their healthcare provider about the recall.
The recalled product
- Product
- CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129278 P4254108D PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129353 The PowerMidline" Catheter is intended
- Manufacturer
- Bard Access Systems, Inc.
- Affected units
- 2,844
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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