Poly Midline Catheters recalled due to manufacturing defects
Bard Access Systems is recalling Poly Midline 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 a Class II recall with manufacturing deficiency reported but no reported injuries or illnesses mentioned in the source text. The hazard is related to manufacturing practices rather than a high-risk pathogen or confirmed harm, consistent with a Moderate severity classification.
Plain-English summary
Bard Access Systems, Inc. is recalling Poly Midline Catheters, models CK000495A and CK000566, with UDI-DI codes 00801741121609, 00801741108051, and 00801741108051. The catheters are intended for short or long-term peripheral venous access for intravenous therapies and blood sampling.
The recall is due to lidocaine ampoules being manufactured under deficient manufacturing practices by the manufacturer. Approximately 3,240 units were distributed worldwide, including nationwide distribution across all U.S. states and territories, as well as Belgium.
The affected lot numbers are REKV1588 (CK000495A), REKX0938 (CK000566), and REKY1965 (CK000566). Patients and healthcare providers in possession of these products should discontinue use and contact Bard Access Systems, Inc. for further instructions.
The recalled product
- Product
- CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 The Poly Per-Q-Cath Midline…
- Manufacturer
- Bard Access Systems, Inc.
- Affected units
- 3,240
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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