FDAFDA · Food and drugs·Recall number Z-2663-2026
CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129278 P4254108D PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129353 The PowerMidline" Catheter is intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media.
Published July 8, 2026 · Recall initiated: May 21, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bard Access Systems, Inc.
- Distributor
- 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.
- Lot
- CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 Lot Number: REKX0112 P4254108 PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129278 Lot Number: REKW0949 P4254108D PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129353 Lot Number: REJZ1337
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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