Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Sec...
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 ...
Z-1990-2020May 20, 2020Mansfield, MA
ICU Medical, Inc.
Class IITerminated
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 414...
Reason: Inability for the guidewire to pass through the needles included with the catheter kits.
Reason: The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VCLAS) kit, including incorrect Luer connector assembly, incorrect drip-chamber assem...
Reason: The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.
Reason: The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.
Reason: The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.
Z-1846-2020May 13, 2020Rancho Santa Margarita, CA
Becton Dickinson & Company
Class IITerminated
CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) 210930(10)0001304986
Reason: The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle.
Z-1795-2020May 6, 2020Franklin Lakes, NJ
Vascular Solutions, Inc.
Class ITerminated
Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
Reason: The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Z-1747-2020May 6, 2020Maple Grove, MN
Degania Medical Devices Pvt. Ltd.
Class IITerminated
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Reason: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Z-1789-2020April 29, 2020Gurgaon, N/A
Degania Medical Devices Pvt. Ltd.
Class IITerminated
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Reason: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Z-1787-2020April 29, 2020Gurgaon, N/A
Degania Medical Devices Pvt. Ltd.
Class IITerminated
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Reason: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Z-1779-2020April 29, 2020Gurgaon, N/A
Degania Medical Devices Pvt. Ltd.
Class IITerminated
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Reason: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Z-1783-2020April 29, 2020Gurgaon, N/A
Degania Medical Devices Pvt. Ltd.
Class IITerminated
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Reason: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Z-1785-2020April 29, 2020Gurgaon, N/A
Degania Medical Devices Pvt. Ltd.
Class IITerminated
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Reason: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Z-1784-2020April 29, 2020Gurgaon, N/A
Degania Medical Devices Pvt. Ltd.
Class IITerminated
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Reason: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Z-1788-2020April 29, 2020Gurgaon, N/A
Degania Medical Devices Pvt. Ltd.
Class IITerminated
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Reason: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Z-1786-2020April 29, 2020Gurgaon, N/A
Degania Medical Devices Pvt. Ltd.
Class IITerminated
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Reason: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Reason: It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay...
Z-1768-2020April 29, 2020Carlsbad, CA
Degania Medical Devices Pvt. Ltd.
Class IITerminated
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Reason: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Z-1781-2020April 29, 2020Gurgaon, N/A
Degania Medical Devices Pvt. Ltd.
Class IITerminated
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Reason: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Z-1782-2020April 29, 2020Gurgaon, N/A
CooperSurgical, Inc.
Class IIITerminated
Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the i...
Reason: Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years.
Reason: The firm has become aware of a potential problem that their Catheters may break/fracture and/or kink/bend if improperly removed from the packaging/dispenser hoop or during catheter...
Reason: The firm has become aware of a potential problem that their Catheters may break/fracture and/or kink/bend if improperly removed from the packaging/dispenser hoop or during catheter...
Z-1620-2020April 8, 2020Fremont, CA
Bard Peripheral Vascular Inc
Class IITerminated
BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S005...
Reason: The firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at risk of experiencing a magnetic deficiency, which may result in the mag...
Z-1637-2020April 8, 2020Tempe, AZ
LeMaitre Vascular, Inc.
Class IOngoing
LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli a...
Reason: There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.