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 Medical Recalls CE17TKFSA Full Tray Catheter Connectors
B. Braun Medical is recalling CE17TKFSA full trays because the catheter connectors may not stay closed, leading to leakage or disconnection.
Product
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 point to a catheter for delivery of anesthetics. The connector is used in conjunct
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HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls Epidural Catheter Connectors Due to Leakage
B. Braun Medical is recalling 1,760 CE18TOD epidural tray connectors because they may not stay closed, leading to leakage or disconnection.
Product
CE18TOD CONT EPIDURAL TRAY LF, Material Number 332236 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 th
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HighFDA (Devices)··2018-10-10
B. Braun Accu-Bloc Perifix Kit Recalled for Catheter Leakage
B. Braun Medical is recalling 1,380 Accu-Bloc Perifix Kits because the catheter connectors may not stay closed, leading to leakage or disconnection.
Product
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 catheter for delivery of anesthetics. The connector is used in conjunction with
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HighFDA (Devices)··2018-10-10
B. Braun Perifix FX Catheter Connectors Recalled for Leakage and Disconnection
B. Braun Medical is recalling Perifix FX catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
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 point to a catheter for delivery of anesthetics. The connector is used in conjuncti
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HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls Catheter Connectors Due to Leakage and Disconnection
B. Braun Medical is recalling 600 CONTI TUOHY ULTRA 360 catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
CONTI TUOHY ULTRA 360 2 IN CONT PNB SET, Material Number 331640 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
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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 conjuncti
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HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls Epidural Anesthesia Kits Due to Leakage
B. Braun Medical is recalling CE17TKCD epidural anesthesia kits because the catheter connectors may not stay closed, leading to leakage or disconnection.
Product
CE17TKCD CONT EPIDURAL ANESTHESIA KIT, Material Number 332229 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 Tuohy Ultra Catheter Connectors
B. Braun Medical is recalling 168 Contiplex Tuohy Ultra 2-in-1 connector sets because the connectors may not stay closed, leading to leakage or disconnection.
Product
CONTIPLEX TUOHY ULTRA 2 IN CONT. PNB SET, Material Number 331673 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 conjunct
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HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls CE18TKDP Catheter Connectors Due to Leakage
B. Braun Medical is recalling CE18TKDP catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
CE18TKDP CONT EPID/DURAPREP, Material Number 332215 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 18GA Tuohy Catheter Connectors for Leakage
B. Braun Medical is recalling 18GA Tuohy catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
CE18TKCD10L 18GA TUOHY/10CC GLAS, Material Number 332217 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 Recalls Epidural Catheter Connectors Due to Leakage and Disconnection
B. Braun Medical is recalling 4,150 epidural catheter connectors because they may not stay closed, causing leakage or disconnection.
Product
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 catheter for delivery of anesthetics. The connector is used in conjunction with t
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HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls CE18H Continuous Epidural Sets
B. Braun Medical is recalling CE18H Continuous Epidural Sets because the catheter connectors may not stay closed, potentially causing leakage or disconnection.
Product
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 for delivery of anesthetics. The connector is used in conjunction with the cath
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HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls EC20CST 20G Soft Tip Catheter Connectors
B. Braun Medical is recalling EC20CST 20G Soft Tip Catheter Connectors because they may not stay closed, leading to leakage or disconnection.
Product
EC20CST 20G CLSD SOFT TIP CATH, Material Number 333521 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
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HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls CE18TKST Epidural Catheter Connectors
B. Braun Medical is recalling CE18TKST epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
CE18TKST CONT EPID W/SOFT TIP, Material Number 332081 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 th
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HighFDA (Devices)··2018-10-10
B. Braun Recalls CE17TKFS Epidural Trays Due to Connector Leakage
B. Braun Medical is recalling CE17TKFS Epidural Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.
Product
CE17TKFS EPIDURAL TRAY, Material Number 332098 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 cathe
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SevereFDA (Devices)··2018-10-10
B. Braun Medical Recalls Contiplex Tuohy Sets Due to Leakage
B. Braun Medical is recalling 1,848 Contiplex Tuohy Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.
Product
CONTIPLEX TUOHY SET, 18GX11/2X 1,3X40MM, Material Number 331695 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
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HighFDA (Devices)··2018-10-10
B. Braun Contiplex Cont Nerve Block Connectors Recalled for Leakage
B. Braun Medical is recalling Contiplex Cont Nerve Block connectors because they may not stay closed, leading to leakage or disconnection.
Product
CNBFX350C CONTIPLEX CONT NERVE BLOCK, Material Number 331672 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 EC20O Catheter Connectors Due to Leakage
B. Braun Medical is recalling EC20O catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
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 a catheter for delivery of anesthetics. The connector is used in conjunction wi
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