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Medium risk Medical DevicesClass II

Bard Poly Midline Catheter Recall

CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code:

Updated May 21, 2026

Bard Access Systems is recalling Poly Midline Catheters (models CK000495A and CK000566) because the lidocaine supplied with these catheters was made under deficient manufacturing practices. This could affect the safety and sterility of the product.

Is the Bard Access Systems, Inc. recalled? Yes. This product was recalled by FDA on May 21, 2026. Details below.

What is recalled

Bard Access Systems Poly Midline Catheter 4 Fr Single-Lumen catheters: Model CK000495A (UDI-DI Code 00801741121609) and Model CK000566 (UDI-DI Code 00801741108051).

Am I affected

You are affected if you have a Poly Midline Catheter from Bard Access Systems with model number CK000495A or CK000566, or if your healthcare provider ordered these models for you.

What to do right now

Contact your healthcare provider or Bard Access Systems immediately to discuss whether you have one of these catheters and what steps to take. Do not use the product until you have spoken with your provider or the manufacturer.

The hazard

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Brands affected

Bard Access Systems, Inc.
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2656-2026
Classification
Class II
Recalled
May 21, 2026
Read the official notice

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