FDA (Devices) recall action 80811

B. Braun Medical, Inc. recalled 93 products on 2018-10-10

The FDA (Devices) publishes a recall like this one as 93 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 93 pages.

Products: 93
Announced: 2018-10-10
Critical: 0
Units: 1,208,477

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

51–75 of 93

HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls CE18TBLS Epidural Tray Connectors
B. Braun Medical is recalling CE18TBLS epidural tray connectors because they may not stay closed, leading to leakage or disconnection.
Product
CE18TBLS CONT EPIDURAL TRAY, Material Number 332219 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls Spinal and Epidural Catheter Connectors
B. Braun Medical is recalling ES1827KDS Spinal/Epidural Full Kits because the catheter connectors may not stay closed, leading to leakage or disconnection.
Product
ES1827KDS SPINAL/EPIDURAL FULL KIT, Material Number 333194 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction wi
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls CNB200TKU Non-Stim Catheter Full Kits
B. Braun Medical is recalling 880 units of CNB200TKU Non-Stim Catheter Full Kits because the connectors may not stay closed, leading to leakage or disconnection.
Product
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 catheter for delivery of anesthetics. The connector is used in conjunction with
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Recalls CE17T Continuous Epidural Sets Due to Leakage
B. Braun Medical is recalling 504 CE17T Continuous Epidural Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.
Product
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 for delivery of anesthetics. The connector is used in conjunction with the cath
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Recalls Epidural Trays Due to Catheter Connector Leakage
B. Braun Medical is recalling 1,020 epidural trays because catheter connectors may not stay closed, causing leakage or disconnection.
Product
GOVCE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332602 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjuncti
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls CE18TKCD Epidural Catheter Connectors
B. Braun Medical is recalling CE18TKCD epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
CE18TKCD CONT EPIDURAL TRAY, Material Number 332211 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls Epidural Catheter Connectors Due to Leakage
B. Braun Medical is recalling 93,140 epidural catheter connectors because they may not stay closed, causing leakage or disconnection.
Product
CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF, Material Number 332097 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjuncti
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Catheter Connectors Recalled for Leakage and Disconnection
B. Braun Medical is recalling specific catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
SCNB4TK CONT STIM W/4 INCH INSUL TUOHY, Material Number 331756 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunctio
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls Espocan Spinal/Epid Trays Due to Leakage
B. Braun Medical is recalling 1,490 Espocan Spinal/Epid Trays because the catheter connectors may not stay closed, causing leakage or disconnection.
Product
ESPOCAN SPINAL/EPID TRAY W/ 18G TUOHY, Material Number 333193 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls ESPOCAN Combined 27GA Catheter Connectors
B. Braun Medical is recalling ESPOCAN Combined 27GA catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
ES1827QK ESPOCAN COMBINED 27GA, Material Number 333182 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with t
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Perifix Epidural Tray Recall for Connector Leakage
B. Braun Medical is recalling Perifix Continuous Epidural Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.
Product
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 to a catheter for delivery of anesthetics. The connector is used in conjunction
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls Contiplex Echo OT Catheter Connectors
B. Braun Medical is recalling 190 units of Contiplex Echo OT catheter connectors because they may not stay closed, causing leakage or disconnection.
Product
CONTIPLEX ECHO OT W/4" TUOHY ULTRA SET, Material Number 331762 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunctio
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Catheter Connector Recall Due to Leakage and Disconnection
B. Braun Medical is recalling CONTI CONT 4inTUOHY ULTRA 360 PNB TRAY catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
CONTI CONT 4inTUOHY ULTRA 360 PNB TRAY, Material Number 332143 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunctio
Category
Distribution
0 states
SevereFDA (Devices)··2018-10-10
B. Braun Medical Recalls CE18TB Epidural Trays Due to Leakage
B. Braun Medical is recalling CE18TB epidural trays because the catheter connectors may not stay closed, causing leakage or disconnection.
Product
CE18TB CONT EPIDURAL TRAY, Material Number 332222 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the ca
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Perifix FX Continuous Epidural Set Recalled for Connector Leakage
B. Braun Medical is recalling 1,032 Perifix FX Continuous Epidural Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.
Product
CE17TF PERIFIX FX CONTIN. EPIDURAL SET, Material Number 332234 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunctio
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls ACCU-BLOC PERIFIX Kits Due to Leakage
B. Braun Medical is recalling CE18TK ACCU-BLOC PERIFIX Kits because the catheter connectors may not stay closed, causing leakage or disconnection.
Product
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 catheter for delivery of anesthetics. The connector is used in conjunction with the
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls Non-Stim Catheter Full Kits Due to Leakage
B. Braun Medical is recalling 2,740 CNB400TKU Non-Stim Catheter Full Kits because the connectors may not stay closed, leading to leakage or disconnection.
Product
CNB400TKU NON-STIM CATH FULL KIT, Material Number 332128 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Recalls 2800 Clamp Style Catheter Connectors Due to Leakage
B. Braun Medical is recalling 2,800 clamp style catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
CLAMP STYLE CATHETER CONNECTOR 20GA- LF, Material Number 332283 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjuncti
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls CE17TO Epidural Catheter Connectors
B. Braun Medical is recalling CE17TO epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
CE17TO CONT EPIDURAL SET LF, Material Number 332204 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Contiplex Cont Nerve Block Catheter Connectors Recalled for Leakage
B. Braun Medical is recalling 4,510 units of CNB400TK Contiplex Cont Nerve Block catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
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 to a catheter for delivery of anesthetics. The connector is used in conjunction w
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls Catheter Connectors Due to Leakage and Disconnection
B. Braun Medical is recalling 430 units of CONT STIM BASIC KIT W/4 IN INSUL TUOHY catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
CONT STIM BASIC KIT W/4 IN INSUL TUOHY, Material Number 331758 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunctio
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls Contiplex Tuohy Sets Due to Leakage
B. Braun Medical is recalling 5,460 units of CNB200T Contiplex Tuohy Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.
Product
CNB200T CONTIPLEX TUOHY SET 2 IN, Material Number 331691 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Recalls Spinal and Epidural Catheter Connectors Due to Leakage
B. Braun Medical is recalling ES1827K Spinal/Epidural Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.
Product
ES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 333192 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction wit
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Perifix One Epidural Full Tray Recall for Connector Issues
B. Braun Medical is recalling Perifix One Epidural Full Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.
Product
CE18TKO PERIFIX ONE EPIDURAL FULL TRAY, Material Number 332282 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunctio
Category
Distribution
0 states
HighFDA (Devices)··2018-10-10
B. Braun Catheter Connectors Recalled for Leakage and Disconnection
B. Braun Medical is recalling 1,350 CNB400TU3KUE catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
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 point to a catheter for delivery of anesthetics. The connector is used in conjunctio
Category
Distribution
0 states