TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a ...
Reason: High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter
Z-2541-2020July 15, 2020Plymouth, MN
Smiths Medical ASD Inc.
Class IITerminated
PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.
Reason: Smiths Medical became aware that one (1) lot of PORT-A-CATH¿ II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a 6Fr catheter.
Z-2499-2020July 15, 2020Minneapolis, MN
Bound Tree Medical
Class IITerminated
Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number: KLTSD404K Curaplex Ambu¿ King LTS-D" Supraglottic Airway Kit with ET Tube (hereafter the Kit which contains all of the...
Reason: Kit contained an incorrect catheter-tip syringe not compatible with the luer lock connector of the included airway. As a result, may be unable to inflate the balloons of the supr...
Z-2532-2020July 15, 2020Dublin, OH
Prodimed Plastimed Division
Class IITerminated
Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58229 19
Reason: Lack of assurance of sterility
Z-2490-2020July 15, 2020Le Plessis Bouchard
Prodimed Plastimed Division
Class IITerminated
Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm Product Code: 58216 27US
Reason: Lack of assurance of sterility
Z-2487-2020July 15, 2020Le Plessis Bouchard
Prodimed Plastimed Division
Class IITerminated
Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 19US
Reason: Lack of assurance of sterility
Z-2491-2020July 15, 2020Le Plessis Bouchard
Prodimed Plastimed Division
Class IITerminated
Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH 90 cm x 1.9 mm Product Code: 58229 19US
Reason: Lack of assurance of sterility
Z-2489-2020July 15, 2020Le Plessis Bouchard
Angiodynamics, Inc.
Class IITerminated
BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing ...
Reason: Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
Z-2395-2020June 24, 2020Queensbury, NY
BIOSENSE WEBSTER
Class IITerminated
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode ...
Reason: Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
Z-2371-2020June 24, 2020IRVINE, CA
BIOSENSE WEBSTER
Class IITerminated
PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electr...
Reason: Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
Z-2372-2020June 24, 2020IRVINE, CA
Angiodynamics, Inc.
Class IITerminated
BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature...
Reason: Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
Z-2396-2020June 24, 2020Queensbury, NY
Canon Medical System, USA, INC.
Class IIOngoing
Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration...
Reason: Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
Reason: Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.
Z-2288-2020June 17, 2020Reading, PA
INARI MEDICAL
Class IITerminated
Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079
Reason: The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of vacuum during thrombus aspiration, which may result the procedure being prolonged ...
Z-2299-2020June 17, 2020Irvine, CA
Canon Medical System, USA, INC.
Class IIOngoing
Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration...
Reason: Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
Z-2326-2020June 17, 2020Tustin, CA
Canon Medical System, USA, INC.
Class IIOngoing
Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration...
Reason: Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
Reason: Incorrect Peel-Apart Introducer Sheath in Kit.
Z-2208-2020June 10, 2020Tempe, AZ
Argon Medical Devices, Inc
Class IITerminated
Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle pu...
Reason: Tungsten coils of the guidewire included in the introducer kit were detaching.
Z-2109-2020June 3, 2020Athens, TX
Medtronic Vascular Galway DBA Medtronic Ireland
Class ITerminated
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Reason: Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
Z-2039-2020June 3, 2020Galway, N/A
Medline Industries Inc
Class IITerminated
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine ...
Reason: Loose silicone particulate was found to be present on the shaft of the silicone catheters.
Z-2043-2020May 27, 2020Northfield, IL
Medline Industries Inc
Class IITerminated
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urin...
Reason: Loose silicone particulate was found to be present on the shaft of the silicone catheters.
Z-2042-2020May 27, 2020Northfield, IL
Medline Industries Inc
Class IITerminated
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine...
Reason: Loose silicone particulate was found to be present on the shaft of the silicone catheters.
Z-2044-2020May 27, 2020Northfield, IL
Covidien Llc
Class IITerminated
Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use ...
Reason: Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could ...