CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 ...
Reason for Recall / Hazard
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Salt Lake City |
| State | UT |
| Event id | 99096 |
| Address 1 | 605 N 5600 W |
| Address 2 | N/A |
| Code info | 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 |
| Postal code | 84116-3738 |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 2,844 |
| Reason for recall | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260521 |
| Initial firm notification | Letter |
| Center classification date | 20260702 |
Overview
- Recalling FirmBard Access Systems, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide 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.