United StatesBard Access Systems, Inc. is recalling multiple Acute Drainage trays and a range of midline, PICC and short‑term dialysis catheters — examples include OTP5000 THORA/PARA TRAY (UDI‑DI 0110885403284748, Lot REKY3402), PIG1260T SAFE‑T‑CENTESIS TRAY (UDI‑DI 0110885403108365, Lot REKY3397), TPT1000 THORACENTESIS/PARACENTESIS TRAY (UDI‑DI 0110885403108488, Lot REKY3386) and numerous PowerPICC and Power‑Trialysis catheters listed with specific UDI‑DI codes and lot numbers. The recall was initiated because lidocaine ampoules used with these products were manufactured under deficient manufacturing practices and are being recalled by the supplier.
What's being recalled
OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 The Acute Drainage devices are indicated for use in removing fluid from either the pleural or peritoneal spaces during an acute drainage / aspiration procedure.
CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 The Poly Per-Q-Cath Midline catheters are indicated for short or long term peripheral access to the peripheral venous system for selected intravenous therapies and blood sarnpling.
5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 The intended use of the Short-Term Dialysis Catheter is attaining temporary/short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, or apheresis therapy via the jugular, subclavian, or femoral vein.
CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internal reinforcement to aid in catheter placement.
1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen REKV2227 00801741027536 The PowerPlCC SV catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 5605240 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086977 5605300 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086984 5615120 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075087 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 5615200…
5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 5855300 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107184 5865120 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107191 5865200 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI_DI Code: 00801741107214 5865240 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107221 The Power-Trialysis Slim-Cath Short-Term Dialysis Catheter, with a…
CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138713 P4153108D PowerMidline Catheter 3 Fr Single-lumen UDI-DI Code: 00801741108747 P4154108 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108754 P4154108D PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108761 The PowerMidline" Catheter is intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media.
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.
CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 CK000883 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188800 CK000884A PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741219177 CK001000 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741223020 CK001066 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741228544 CK001068 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741228728 S1173108D PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741130342 S1173108D1 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154720 S1173108D4 PowerPICC Provena…
7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Groshong¿ NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.
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…
CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154003 S4153108BP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153990 S4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153952 S4153108DCP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741233258 S4153108DGP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154027 S4254108BD Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154140 S4254108BDP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154164 S4254108D Provena Midline Catheter 4 Fr…
4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108501 The Soft Tissue Biopsy devices are indicated for use in the collection of aspirate tissue (e.g. liver, kidney, etc.).
Recalling firm: Bard Access Systems, Inc., Salt Lake City, UT, United States.
How to identify it
OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 Lot Number: REKY3402 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 Lot Number: REKY3397 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 Lot Number: REKY3386 CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 Lot Number: REKV1588 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 Lot Number: REKX0938 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 Lot Number: REKY1965 5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 Lot Number: REKY0255 CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Lot Number: REKT1554 1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741087110 Lot Number: REKW2449 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741027536 Lot Number: REKV2227 5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 Lot Number: REKX1755 5605240 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086977 Lot Number: REKW0663 5605300 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086984 Lot Number: REKY2472 5615120 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075087 Lot Number: REKZ0393 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 Lot Number: REKQ1130 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 Lot Number: REKX3745 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 Lot Number: REKY2418 5655120 Power-Trialysis Short-Term Alphacurve Dialysis Catheter 13…
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
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada