Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Foley Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P16TS - Product Usage...
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-1989-2020May 20, 2020Mansfield, MA
Argon Medical Devices, Inc
Class IITerminated
PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indicated for use in arterial and venous procedures requiring percut...
Reason: Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may ...
Z-1938-2020May 20, 2020Athens, TX
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.
Z-1999-2020May 20, 2020San Clemente, CA
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.
Z-2001-2020May 20, 2020San Clemente, CA
Cook Inc.
Class IITerminated
Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel with a slotted tube configuration. It is pre-mount...
Reason: The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon delivery system prior to deployment. Use of affected product may lead ...
Z-1940-2020May 20, 2020Bloomington, IN
C.R. Bard Inc
Class IITerminated
SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the ur...
Reason: There is potential for a white paper-type residue attached to the catheter.
Z-1970-2020May 20, 2020Covington, GA
Edwards Lifesciences, LLC
Class IITerminated
Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any a...
Reason: Intermittent communication due to inconsistent crimping of connectors onto cables.
Z-1928-2020May 20, 2020Irvine, CA
Covidien Llc
Class IITerminated
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and...
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-1994-2020May 20, 2020Mansfield, MA
Covidien Llc
Class IITerminated
Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and...
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-1992-2020May 20, 2020Mansfield, MA
Argon Medical Devices, Inc
Class IITerminated
Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressu...
Reason: Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may ...
Z-1936-2020May 20, 2020Athens, TX
Covidien Llc
Class IITerminated
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR 5CCCC2W, Product Code: 50518ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring ...
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-1987-2020May 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 # 504...
Reason: Inability for the guidewire to pass through the needles included with the catheter kits.
Z-2002-2020May 20, 2020San Clemente, CA
Covidien Llc
Class IITerminated
Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Secu...
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-1988-2020May 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.
Z-1998-2020May 20, 2020San Clemente, CA
Becton Dickinson & Company
Class IITerminated
PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D
Reason: Iincorrectly packaged without the required lidocaine as labeled
Z-1946-2020May 20, 2020Franklin Lakes, NJ
Bard Peripheral Vascular Inc
Class IIOngoing
BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials...
Reason: The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.
Z-1964-2020May 20, 2020Tempe, AZ
Covidien Llc
Class IITerminated
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring...
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-1985-2020May 20, 2020Mansfield, MA
Argon Medical Devices, Inc
Class IITerminated
Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressur...
Reason: Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may ...
Z-1937-2020May 20, 2020Athens, TX
Covidien Llc
Class IITerminated
Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescripti...
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-1984-2020May 20, 2020Mansfield, MA
Access Scientific LLC
Class IITerminated
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter. REF/UDI / 94108/00859821006773 - Product Usage: is used to gain access to the vascular system to sampl...
Reason: Saline Flush Syringe compromised sterility due to holes in the packaging.
Z-1979-2020May 20, 2020San Diego, CA
Ra Medical Systems, Inc.
Class IITerminated
Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Revis...
Reason: The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf life is currently les...
Z-2006-2020May 20, 2020Carlsbad, CA
Covidien Llc
Class IITerminated
Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, T...
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-1991-2020May 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. LOT Number ...
Reason: Inability for the guidewire to pass through the needles included with the catheter kits.
Z-1996-2020May 20, 2020San Clemente, CA
Covidien Llc
Class IITerminated
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray,18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: ...
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-1993-2020May 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.