{"url_path":"/fda/device/recalls/Z-2663-2026","section_key":"summary","section_title":"DEVICE Recall: Bard Access Systems, Inc. — CK000980A\tPowerMidline Catheter 4 Fr Dual-Lumen  UDI-DI Code: 00801741236150    P4254108\tPowerMidline Catheter 4 Fr Dual-Lumen  UDI-DI Code: 00801741129278    P4254108D\tPowerMidline Catheter 4 Fr Dual-Lumen  UDI-DI Code: 00801741129353      The PowerMidline\" Catheter is intended for short term peripheral access for selected intravenous therapies, blood s…","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-21","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2663-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Bard Access Systems, Inc."},"word_count":204,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2663-2026\n\n**Recalling firm:** Bard Access Systems, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-21\n**Report date:** 2026-07-08\n\n## Product\nCK000980A\tPowerMidline Catheter 4 Fr Dual-Lumen  UDI-DI Code: 00801741236150    P4254108\tPowerMidline Catheter 4 Fr Dual-Lumen  UDI-DI Code: 00801741129278    P4254108D\tPowerMidline 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.\n\n## Reason\nDue to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.\n\n## Affected lots\nCK000980A 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\n\n## Distribution\nWorldwide 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."}