Z-2656-2026Class II

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

Name: Z-2656-2026 CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter...
Creator: Bard Access Systems, Inc.
Published: 2026-05-21
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2026-05-21 / Open, Classified / root cause: manufacturing process

FDA source

Bard Access Systems, Inc. began a recall of CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051... on 2026-05-21. FDA classified it as Class II and gives the reason as "Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2656-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-21
Posted: 2026-07-02
Recalling firm: Bard Access Systems, Inc.
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 catheters are indicated for short or long term peripheral access to the peripheral venous system for selected intravenous therapies and blood sarnpling.
Product code: PXI Thoracentesis Tray
Reason for recall: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 05/21/2026, the firm FedEx'd an "URGENT: Medical Device Recall" letter informing customers/distributed that BD has become aware that the FDA has placed Lidocaine manufactured by Huons Co., Ltd. on import alert #66-40 - Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs. BD is recalling products that contain the affected lidocaine ampules. Customers are instructed to: 1. Not to use the affected Lidocaine ampules. 2. Secure an alternative local Lidocaine drug prior to entering the procedural environment. 3. Upon opening the kit, remove and destroy the drug product from the BD convenience kits/procedure trays at the point of use, within a controlled and sterile environment to maintain the sterility of the remaining components within the kit. All other kit/tray components are safe to use. 4. If affected Lidocaine ampule was previously used without issue, no additional treatment or clinical follow up is required. 5. If affected Lidocaine ampule was previously used with issue, report the incident per institutional guidelines and take any necessary actions. Additional actions to take: 1. Circulate this notice to all those who need to be aware within your organization or to any organization where the potentially affected products have been transferred. 2. Post this notice on all inventory storage locations and any location where the product may be used. 3. Label affected kits/trays using the template provided in Appendix 2 to facilitate easy identification of products containing the affected ampules. The label can be printed using Avery template 5160. a. Apply the labels to the product without covering or obscuring any regulatory or traceability information. b. Apply to the top web of the kit/tray pressing firmly to ensure adhesion, while taking care not to damage or compromise the sterile barrier. For Questions - Contact North American Regional Complaint Center at 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompt
Quantity in commerce: 3,240
Distribution: Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.
Product codes and lots: CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 Lot Number: REKV1588 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 Lot Number: REKX0938 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 Lot Number: REKY1965

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2656-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2655-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2656-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2657-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2658-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2659-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2660-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2661-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2662-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2663-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2664-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2665-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2666-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2667-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02
Z-2668-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02

Product code PXI

K001901Class IIPoly per-Q-Cath Picc Catheter,model 3236100 and Poly per-Q-Cath Midline Catheter, Model 3134135C.R. Bard, Inc. / cleared 2000-09-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)