CLASS II ONGOING Device recall · Reported 8 Jul 2026 · FDA Enforcement Report

CK000880 Provena Midline Catheter Dual-Lumen recalled

Bard Access Systems is recalling CK000880 Provena Midline Catheter Dual-Lumen, distributed nationwide in the US. The recall was initiated on 21 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 Lot Number: REKN2105 S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154003 Lot Numbers: REKW2429 REKX1484 S4153108BP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153990 Lot Number: REKW2494 S4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153952 Lot Numbers: REKP0118 REKX2225 S4153108DCP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741233258 Lot Number: REKX3430 S4153108DGP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154027 Lot Numbers: REKQ0118 REKW1477 S4254108BD Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154140 Lot Number: REKY0144 S4254108BDP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154164 Lot Numbers: REKW0447 REKW0953 REKX2214 S4254108D Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154119 Lot Number: REKX3445 S4254108DCP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741233234 Lot Number: REKW2430 S4254108DGP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154188 Lot Numbers: REKV3192 REKX3437 SP4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741185052 Lot Number: REKW2448 SP4153108DG Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741185069 Lot Number: REKW0959

Quantity recalled24,348

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2667-2026
FDA event ID: 99096
Recalling firm: Bard Access Systems, Salt Lake City, UT
Classification: Class II
Status: Ongoing
Recall initiated: 21 May 2026
FDA classified: 2 Jul 2026
Reported: 8 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

21 May 2026	Recall initiated by company
2 Jul 2026	Classified by FDA	+42 days
8 Jul 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154003 S4153108BP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153990 S4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153952 S4153108DCP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741233258 S4153108DGP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154027 S4254108BD Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154140 S4254108BDP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154164 S4254108D Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154119 S4254108DCP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741233234 S4254108DGP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154188 SP4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741185052 SP4153108DG Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741185069 The Provena" Midline Catheters are intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media.

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

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

Which lots are affected?

CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 Lot Number: REKN2105 S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154003 Lot Numbers: REKW2429 REKX1484 S4153108BP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153990 Lot Number: REKW2494 S4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153952 Lot Numbers: REKP0118 REKX2225 S4153108DCP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741233258 Lot Number: REKX3430 S4153108DGP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154027 Lot Numbers: REKQ0118 REKW1477 S4254108BD Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154140 Lot Number: REKY0144 S4254108BDP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154164 Lot Numbers: REKW0447 REKW0953 REKX2214 S4254108D Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154119 Lot Number: REKX3445 S4254108DCP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741233234 Lot Number: REKW2430 S4254108DGP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154188 Lot Numbers: REKV3192 REKX3437 SP4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741185052 Lot Number: REKW2448 SP4153108DG Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741185069 Lot Number: REKW0959

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

13 other products · FDA event 99096

This product is part of a recall event; the main page for the event is CK000495A Poly Midline Catheter Single-Lumen recalled.

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026	CLASS II	CK000495A Poly Midline Catheter Single-Lumen recalled	Bard Access Systems	Other	Nationwide
8 Jul 2026	CLASS II	5855240 Power-Trialysis Slim-Cath Straight Short-Term recalled	Bard Access Systems	Other	Nationwide
8 Jul 2026	CLASS II	CK000727 PowerMidline Catheter Single-Lumen recalled	Bard Access Systems	Other	Nationwide
8 Jul 2026	CLASS II	5625240 DuoGlide Short-Term Straight Dialysis Catheter Dual-Lumen recalled	Bard Access Systems	Other	Nationwide
8 Jul 2026	CLASS II	CK000525B PowerPICC Provena SOLO Catheter Dual-Lumen recalled	Bard Access Systems	Other	Nationwide
8 Jul 2026	CLASS II	1274108D PowerPICC SV Catheter Dual-Lumen REKW2449 recalled	Bard Access Systems	Other	Nationwide
8 Jul 2026	CLASS II	CK000662 PowerPICC SOLO HF Catheter Triple-Lumen recalled	Bard Access Systems	Other	Nationwide
8 Jul 2026	CLASS II	Otp5000 Thora/para Tray, Non-valved recalled by Bard Access Systems	Bard Access Systems	Other	Nationwide
8 Jul 2026	CLASS II	7617408 Groshong NXT ClearVue Catheter Single-Lumen recalled	Bard Access Systems	Other	Nationwide
8 Jul 2026	CLASS II	CK000980A PowerMidline Catheter Dual-Lumen recalled	Bard Access Systems	Other	Nationwide
8 Jul 2026	CLASS II	4380 Economy Soft Tissue Biopsy Tray recalled by Bard Access Systems	Bard Access Systems	Other	Nationwide
8 Jul 2026	CLASS II	1174108 PowerPICC Catheter Single-Lumen recalled by Bard Access Systems	Bard Access Systems	Other	Nationwide
8 Jul 2026	CLASS II	5605150 Power-Trialysis Short-Term Straight Dialysis recalled	Bard Access Systems	Other	Nationwide

More recalls from Bard Access Systems

All 65

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS I	DuoGlide Short-Term Straight Dialysis Catheter recalled	Bard Access Systems	Other	50 states
23 Sep 2026Device	CLASS I	Power-Trialysis Short-Term Straight Dialysis Catheter recalled	Bard Access Systems	Other	50 states
26 Aug 2026Device	CLASS I	BD Needle Kit for Powered Driver recalled by Bard Access Systems	Bard Access Systems	Other	32 states
8 Jul 2026Device	CLASS II	5605150 Power-Trialysis Short-Term Straight Dialysis recalled	Bard Access Systems	Other	Nationwide
8 Jul 2026Device	CLASS II	1174108 PowerPICC Catheter Single-Lumen recalled by Bard Access Systems	Bard Access Systems	Other	Nationwide

Other Heart & Vascular Devices recalls

All 6,212

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS I	Imager II Angiographic Catheters M001314001 Imager recalled	Boston Scientific	Other	Nationwide
30 Sep 2026Device	CLASS II	Olympus EZDilate Endoscopic Balloon Dilator Wired-guided recalled	Olympus Corporation of the Americas	Other	PA
30 Sep 2026Device	CLASS II	Cardioroot Woven Collagen Coated Vascular Graft recalled	SAS Intervascular	Other	Nationwide
30 Sep 2026Device	CLASS II	Automated Impella Controller (AIC) recalled by Abiomed	Abiomed	Potency & Assay	Nationwide
23 Sep 2026Device	CLASS I	DuoGlide Short-Term Straight Dialysis Catheter recalled	Bard Access Systems	Other	50 states