Recall Z-2663-2026— Bard Access Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Bard Access Systems, Inc., initiated 2026-05-21. It names one FDA 510(k) clearance: K162900. Product: 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.. Reason: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier..
- Recalling firm
- Bard Access Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-05-21
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Data sourced from openFDA. This site is unofficial and independent of the FDA.