Class II U.S. Food and Drug Administration

Bard Access Systems, Inc. 1174108 PowerPicc Catheter 4 Fr Single-Lumen Udi-Di Code recall: Due to lidocaine ampoules being manufactured under deficient manufacturing

Recall published 4 months ago

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

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2666-2026
Published
July 8, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Bard Access Systems, Inc.
Product type
Medical devices
Units affected
39,245
Distribution
Nationwide
Made in
United States
Lot / code info
1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 Lot Numbers: REKW0930 REKX0625 1295108 PowerPICC SOLO Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034602 Lot Number: REKX2233 1174108D3 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 Lot Number: REKW2495 1174108D4 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155048 Lot Number: REKW0912 1174108D5 PowerPICC Catheter 4 Fr Singel-Lumen UDI-DI Code: 00801741155147 Lot Number: REKW0980 1194108D PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741034510 Lot Number: REKW2454 1194108D1 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154782 Lot Number: REKX0643 1194108D4 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155093 Lot Number: REKW1471 1194108D5 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155192 Lot Number: REKY0121 1275108D PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034558 Lot Number: REKW0913 1295108FD PowerPICC SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034626 Lot Numbers: REKP1491 REKW1478 REKX0051 3194108D PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741027727 Lot Numbers: REKW0937 REKX0095 3275108D PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741027871 Lot Number: REKP0933 3295108D PowerPICC SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741028052 Lot Numbers: REKN0696 REKW0451 9194108D PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035609 Lot Number: REKW2499 CK000267A PowerPICC SOLO2 Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741185021 Lot Number: REKU2372 CK000289C PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741161148 Lot Number: REKP0950 CK000293 PowerPICC HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741038020 Lot Number: REKN2100 CK000586B PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741212789 Lot Number: REKY1980 CK000613 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121395 Lot Number: REKX0904 CK000631B PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741143748 Lot Number: REKW2466 CK000632B PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741143755 Lot Number: REKX3758 CK000746A PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741227066 Lot Number: REKX1896 CK000886 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741188831 Lot Number: REKW2474 CK000966A PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741215858 Lot Number: REKP0918 CK000988 PowerPICCProvena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741216022 Lot Numbers: REKW0468 REKX2706 CK001006 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741219849 Lot Number: REKX0941 CK001030 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741223976 Lot Number: REKY1950 S1275108FD2 PowerPICC Provena FT Catheter 5 Fr Dual-Lumen UDI-Di Code: 00801741154850 Lot Number: REKX0671 S1275108FD3 PowerPICC Provena FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741154959 Lot Number: REKX0661 S1295108FD1 PowerPICC Provena Catheter SOLO 5 Fr Dual-Lumen UDI-DI Code: 00801741154805 Lot Number: REKW1459 S1295108FD3 PowerPICC Provena SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741155017 Lot Number: REKW1476 S1295108FD5 PowerPICC Provena SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741155215 Lot Number: REKW0911 S1385108D PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741112720 Lot Number: REKW0473 S1385108D2 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154867 Lot Number: REKX0641 S1385108D3 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154966 Lot Number: REKW1470 S1385108D4 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155079 Lot Number: REKW2521 S1395108D PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741112751 Lot Number: REKW2446 S1395108D1 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154812 Lot Number: REKW0475 S13951…
UPC codes
00801741154935, 00801741034602, 00801741155048, 00801741155147, 00801741034510, 00801741154782, 00801741155093, 00801741155192, 00801741034558, 00801741034626, 00801741027727, 00801741027871, 00801741028052, 00801741035609, 00801741185021, 00801741161148, 00801741038020, 00801741212789, 00801741121395, 00801741143748

Products covered by this recall

1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC SOLO Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034602 1174108D3 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1174108D4 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155048 1174108D5 PowerPICC Catheter 4 Fr Singel-Lumen UDI-DI Code: 00801741155147 1194108D PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741034510 1194108D1 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154782 1194108D4 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155093 1194108D5 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155192 1275108D PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034558 1295108FD PowerPICC SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034626 3194108D PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741027727 3275108D PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741027871 3295108D PowerPICC SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741028052 9194108D PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035609 CK000267A PowerPICC SOLO2 Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741185021 CK000289C PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741161148 CK000293 PowerPICC HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741038020 CK000586B PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741212789 CK000613 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121395 CK000631B PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741143748 CK000632B PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741143755 CK000746A PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741227066 CK000886 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741188831 CK000966A PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741215858 CK000988 PowerPICCProvena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741216022 CK001006 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741219849 CK001030 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741223976 S1275108FD2 PowerPICC Provena FT Catheter 5 Fr Dual-Lumen UDI-Di Code: 00801741154850 S1275108FD3 PowerPICC Provena FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741154959 S1295108FD1 PowerPICC Provena Catheter SOLO 5 Fr Dual-Lumen UDI-DI Code: 00801741154805 S1295108FD3 PowerPICC Provena SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741155017 S1295108FD5 PowerPICC Provena SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741155215 S1385108D PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741112720 S1385108D2 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154867 S1385108D3 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154966 S1385108D4 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155079 S1395108D PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741112751 S1395108D1 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154812 S1395108D2 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154911 S1395108D3 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155024 S1395108D4 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155123 S1395108D5 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155222

Check your product

The notice names 21 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00801741154935
  • 00801741034602
  • 00801741155048
  • 00801741155147
  • 00801741034510
  • 00801741154782
  • 00801741155093
  • 00801741155192
  • 00801741034558
  • 00801741034626
  • 00801741027727
  • 00801741027871
  • 00801741028052
  • 00801741035609
  • 00801741185021
  • 00801741161148
  • 00801741038020
  • 00801741212789
  • 00801741121395
  • 00801741143748

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • REKW0475 S13951

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Bard Access Systems, Inc. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Bard Access Systems, Inc. — 605 N 5600 W, Salt Lake City, UT, 84116-3738

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Bard Access Systems, Inc. medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00801741154935, 00801741034602, 00801741155048; lot code REKW0475 S13951. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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