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.
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. 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.
See all 14 products in this recall →Related recalls
Same manufacturer · Bard Access Systems, Inc.
See all →- SevereBard Access Systems Recalls Power-Trialysis Dialysis Catheters
FDA (Devices) · 2026-09-23
- SevereBard Access Systems Recalls DuoGlide Short-Term Dialysis Catheters
FDA (Devices) · 2026-09-23
- SevereBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- ModeratePowerPICC Provena Catheters recalled for deficient manufacturing practices
FDA (Devices) · 2026-07-08
- ModeratePoly Midline Catheters recalled due to manufacturing defects
FDA (Devices) · 2026-07-08
Same hazard · deficient manufacturing
See all →- ModerateSoft Tissue Biopsy Trays recalled due to deficient manufacturing practices
FDA (Devices) · 2026-07-08
- ModerateProvena Midline Catheters recalled due to deficient manufacturing practices
FDA (Devices) · 2026-07-08
- ModeratePowerMidline Catheters Recalled for Deficient Manufacturing Practices
FDA (Devices) · 2026-07-08
- ModerateDuoGlide Short-Term Dialysis Catheter recall due to deficient manufacturing
FDA (Devices) · 2026-07-08
- ModeratePower-Trialysis Slim-Cath Dialysis Catheters Recalled by Bard Access Systems
FDA (Devices) · 2026-07-08
Similar recalls
- ModerateBard Access Systems Recalls MRI Low Profile Ports with Undersized Catheters
FDA (Devices) · 2014-01-29
- SevereBD 4 Fr Single-Lumen PowerPICC Catheters Recall Risk of Leaks
FDA (Devices) · 2025-04-23
- HighBard Access Systems Recalls PowerPICC Provena Catheters Due to Possible Leaks
FDA (Devices) · 2018-02-14
- HighPowerPICC Catheter Kits Recalled for Incorrect Micro-Introducer Components
FDA (Devices) · 2021-07-07
- ModerateBard Access Systems Recalls Low Profile Ports with Undersized Catheters
FDA (Devices) · 2014-01-29
- ModerateBecton Dickinson Recalls Bard 3F SL PowerMidline Full Kits
FDA (Devices) · 2020-11-04