Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 78 of 138
B. Braun Medical, Inc.
Class II Terminated
CNBFX350O CONTIPLEX CONT NERVE BLOCK, Material Number 331670 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point ...
Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Z-3314-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CE17TFC CONTINUOUS EPID SET W/17G TUOHY, Material Number 332238 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access poi...
Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Z-3374-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CE17TK19CDP CONT EPIDURAL TRAY, Material Number 332262 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a c...
Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Z-3376-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
EC20CS EPIDURAL CATHETER, Material Number 333532 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a cathete...
Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Z-3401-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CE18HK ACCU-BLOC PERIFIX KIT, Material Number 332230 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a cat...
Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Z-3368-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
EC20O 20G X 100CM CATH OPEN TIP LF, Material Number 333520 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to...
Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Z-3399-2018 October 10, 2018 Allentown, PA
Shockwave Medical, Inc.
Class II Terminated
The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femor...
Reason: Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).
Z-3247-2018 October 3, 2018 Fremont, CA
Medtronic Vascular
Class III Terminated
Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Reason: Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the ...
Z-3253-2018 October 3, 2018 Danvers, MA
Degania Silicone, Ltd.
Class II Terminated
Temperature sensing catheter 18FR, Catalogue Number 102203101863DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is ...
Reason: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Z-2783-2018 September 26, 2018 Dganya Bet, N/A
Degania Silicone, Ltd.
Class II Terminated
Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the thi...
Reason: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Z-2765-2018 September 26, 2018 Dganya Bet, N/A
Degania Silicone, Ltd.
Class II Terminated
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101880MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in...
Reason: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Z-2774-2018 September 26, 2018 Dganya Bet, N/A
COVIDIEN LLC
Class II Terminated
400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD
Reason: The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Z-3205-2018 September 26, 2018 Mansfield, MA
Degania Silicone, Ltd.
Class II Terminated
Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is in...
Reason: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Z-2757-2018 September 26, 2018 Dganya Bet, N/A
Degania Silicone, Ltd.
Class II Terminated
Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is i...
Reason: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Z-2759-2018 September 26, 2018 Dganya Bet, N/A
Degania Silicone, Ltd.
Class II Terminated
Temperature sensing catheter 14FR, Catalogue Number 102203101463DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is ...
Reason: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Z-2781-2018 September 26, 2018 Dganya Bet, N/A
Degania Silicone, Ltd.
Class II Terminated
Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It...
Reason: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Z-2778-2018 September 26, 2018 Dganya Bet, N/A
COVIDIEN LLC
Class II Terminated
400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD
Reason: The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Z-3203-2018 September 26, 2018 Mansfield, MA
Arrow International Inc
Class II Terminated
4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2
Reason: The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 ...
Z-3199-2018 September 26, 2018 Reading, PA
Arrow International Inc
Class II Terminated
ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology s...
Reason: Products are labeled with an incorrect expiration date
Z-3197-2018 September 26, 2018 Reading, PA
Degania Silicone, Ltd.
Class II Terminated
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201100880MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in...
Reason: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Z-2772-2018 September 26, 2018 Dganya Bet, N/A
Degania Silicone, Ltd.
Class II Terminated
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in...
Reason: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Z-2775-2018 September 26, 2018 Dganya Bet, N/A
Degania Silicone, Ltd.
Class II Terminated
Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. I...
Reason: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Z-2754-2018 September 26, 2018 Dganya Bet, N/A
Degania Silicone, Ltd.
Class II Terminated
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101480MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in...
Reason: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Z-2773-2018 September 26, 2018 Dganya Bet, N/A
Degania Silicone, Ltd.
Class II Terminated
Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the thi...
Reason: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Z-2766-2018 September 26, 2018 Dganya Bet, N/A
Degania Silicone, Ltd.
Class II Terminated
Temperature sensing catheter 14FR, Catalogue Number 102201101463NU Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is ...
Reason: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Z-2784-2018 September 26, 2018 Dganya Bet, N/A