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.

76–93 of 93

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…
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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…
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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…
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HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls EC19CF Catheter Connectors Due to Leakage
B. Braun Medical is recalling EC19CF catheter connectors because they may not stay closed, causing leakage or disconnection.
Product
EC19CF 19G X 100CM CATH CLOSED TIP LF, Material Number 333512 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…
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HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls CE18HB Epidural Catheter Connectors
B. Braun Medical is recalling CE18HB epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
CE18HB CONT EPIDURAL HUSTEAD, Material Number 332223 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…
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HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls CE18TKPS Epidural Catheter Connectors
B. Braun Medical is recalling CE18TKPS epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
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 catheter for delivery of anesthetics. The connector is used in conjunction…
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HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls Espocan Spinal/Epidural Trays Due to Leakage
B. Braun Medical is recalling Espocan Spinal/Epidural Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.
Product
ES1725KFX ESPOCAN SPINAL/EPID. TRAY, Material Number 333196 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…
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HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls CE17TFC Continuous Epidural Sets
B. Braun Medical is recalling CE17TFC Continuous Epidural Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.
Product
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 point to a catheter for delivery of anesthetics. The connector is used in…
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HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls CONTIPLEX CONT 4 IN TUOHY ULTRA PNB Trays
B. Braun Medical is recalling 340 units of CONTIPLEX CONT 4 IN TUOHY ULTRA PNB trays because the catheter connectors may not stay closed, leading to leakage or disconnection.
Product
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 point to a catheter for delivery of anesthetics. The connector is used in…
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HighFDA (Devices)··2018-10-10
B. Braun Recalls Contiplex Tuohy Sets Due to Leakage and Disconnection
B. Braun Medical is recalling 864 Contiplex Tuohy Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.
Product
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 point to a catheter for delivery of anesthetics. The connector is used in…
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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…
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HighFDA (Devices)··2018-10-10
B. Braun EC19C Catheter Connectors Recalled for Leakage and Disconnection
B. Braun Medical is recalling EC19C catheter connectors because they may not stay closed, leading to leakage or disconnection during use.
Product
EC19C 19G X 100CM CATHETER CLOSED, Material Number 333511 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…
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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…
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HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls Contiplex Cont Nerve Block Catheter Connectors
B. Braun Medical is recalling specific lots of Contiplex Cont Nerve Block catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
CNB200TK CONTIPLEX CONT NERVE BLOCK, Material Number 331701 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…
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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…
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HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls CE17TB Epidural Tuohy Connectors Due to Leakage
B. Braun Medical is recalling 12,930 CE17TB Epidural Tuohy connectors because they may not stay closed, causing leakage or disconnection.
Product
CE17TB CONT EPIDURAL TUOHY, Material Number 332224 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…
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HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls CE17TOD Epidural Tray Connectors
B. Braun Medical is recalling CE17TOD epidural tray connectors because they may not stay closed, leading to leakage or disconnection.
Product
CE17TOD CONT EPIDURAL TRAY LF, Material Number 332235 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…
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HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls Epidural Catheter Connectors Due to Leakage
B. Braun Medical is recalling 1,040 epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
CE17TKFSDTD EPID TRAY W/17GA FIXED WING, Material Number 332095 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…
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