Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 76 of 138
B. Braun Medical, Inc.
Class II Terminated
CNB400TU3KUE 18GX4 CONTI THY ULTRA 360, Material Number 332170 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access poin...
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-3349-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
ES1725K SPINAL/EPIDURAL TRAY, Material Number 333165 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-3389-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CONTIPLEX TUOHY SET, 18GX6", 1.3X150MM, Material Number 331694 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access poin...
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-3320-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CONTIPLEX CONT 4 IN TUOHY ULTRA PNB TRAY, Material Number 332129 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access po...
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-3347-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
NES1727KFX W /17GA TUOHY 19GA SPRW OT, Material Number 333197 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-3395-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CNB200TKU NON-STIM CATH FULL KIT, Material Number 332127 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a...
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-3345-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CE18H CONT EPIDURAL SET, Material Number 332210 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter...
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-3355-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CE18TK ACCU-BLOC PERIFIX KIT, Material Number 332220 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-3362-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332079 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-3333-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CE18HKCD CONT EPIDURAL TRAY, Material Number 332206 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a cath...
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-3354-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CE17TKFPS PERIFIX FX CONT. EPID TRAY-LF, Material Number 332087 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-3339-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CE18TKPS CONT EPIDURAL TRAY (LF), Material Number 332216 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a...
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-3359-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY, Material Number 332077 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access poin...
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-3331-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
BULK NONSTERILE PERIFIX CATHETER CONN., Material Number 8451699N Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access po...
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-3405-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CEP18TKO CONT. EPIDURAL PEDIATRIC KIT, Material Number 332290 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-3382-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
GOVES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 332614 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-3388-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CE17TKF PERIFIX CONTIN. EPIDURAL TRAY, Material Number 332086 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-3338-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
GOVCE18TK ACCU-BLOC PERIFIX KIT, Material Number 332600 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a ...
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-3385-2018 October 10, 2018 Allentown, PA
Ellex iScience, Inc.
Class II Terminated
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Reason: Sterility failure found in one of the units in the lot.
Z-0011-2019 October 10, 2018 Fremont, CA
B. Braun Medical, Inc.
Class II Terminated
CNB400TK CONTIPLEX CONT NERVE BLOCK, Material Number 331706 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point t...
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-3324-2018 October 10, 2018 Allentown, PA
ICU Medical, Inc.
Class II Completed
ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access fo...
Reason: Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Both devices had the same listing number. Customers may not be awar...
Z-0069-2019 October 10, 2018 San Clemente, CA
B. Braun Medical, Inc.
Class II Terminated
CE17TK CONT EPIDURALTUOHY, Material Number 332221 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a cathet...
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-3363-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CE17TKFSA FULL TRAY W/17G TUOHY 19G SPRW, Material Number 332080 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access po...
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-3334-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CCE18HK10L CONT EPIDURAL TRAY, Material Number 332264 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a ca...
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-3377-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CE17T CONT EPIDURAL SET, Material Number 332202 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter...
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-3352-2018 October 10, 2018 Allentown, PA