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 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…
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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…
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HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls CE18T Continuous Epidural Sets
B. Braun Medical is recalling CE18T Continuous Epidural Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.
Product
CE18T CONT EPIDURAL SET, Material Number 332200 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 Epidural Catheter Connectors Due to Leakage Risk
B. Braun Medical is recalling 3,050 epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
EPID. CATH. NG, 20GA. CLOSED TIP-LF, Material Number 333541 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 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…
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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 specific catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
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 to a catheter for delivery of anesthetics. The connector is used in…
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HighFDA (Devices)··2018-10-10
B. Braun Recalls Spinal and Epidural Catheter Connectors
B. Braun Medical is recalling 200 spinal/epidural trays because the catheter connectors may not stay closed, leading to leakage or disconnection.
Product
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 to a catheter for delivery of anesthetics. The connector is used in conjunction…
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HighFDA (Devices)··2018-10-10
B. Braun Recalls Pain Management Trays Due to Catheter Leakage
B. Braun Medical is recalling Design Options Pain Management Trays because catheter connectors may not stay closed, leading to leakage or disconnection.
Product
DESIGN OPTIONS¿ PAIN MANAGEMENT TRAY, Material Numbers 530029, 530029, 530031, 530035, 530041, 530048, 530068, 530071, 530083, 530108, 530112, 530122, 530123, 530124, 530132, 530133, 530134, 530138, 530141, 530142, 530149, 530153, 530155, 530159, 530160, 530164, 530168, 530169…
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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…
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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…
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HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls 18GA Safety Tuohy Needle Trays
B. Braun Medical is recalling 2,070 units of 18GA Safety Tuohy Needle Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.
Product
CE18TKY 18GA SAFETY TUOHY NEEDLE TRAY, Material Number 332266 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 1,040 epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
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 catheter for delivery of anesthetics. The connector is used in conjunction with…
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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…
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HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls Contiplex Tuohy Sets Due to Leakage
B. Braun Medical is recalling specific Contiplex Tuohy Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.
Product
CONTIPLEX TUOHY SET, 18GX4", 1.3X100MM, Material Number 331693 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 Epid Paed Full Kit Catheter Connectors
B. Braun Medical is recalling 610 units of Epid Paed Full Kit catheter connectors because they may not stay closed, leading to leakage or disconnection.
Product
EPID PAED FULL KIT 24GA CT NG CATH LF, Material Number 332292 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 Pediatric Epidural Catheter Connectors Due to Leakage
B. Braun Medical is recalling 1,380 pediatric epidural catheter connectors because they may not stay closed, causing leakage or disconnection.
Product
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 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 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…
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HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls Spinal and Epidural Catheter Connectors
B. Braun Medical is recalling ES1725K Spinal/Epidural Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.
Product
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 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 CE17TKPS Continuous Epidural Anesthesia Trays
B. Braun Medical is recalling CE17TKPS Continuous Epidural Anesthesia Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.
Product
CE17TKPS CONTINUOUS EPIDURAL ANES TRAY, Material Number 332233 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 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 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…
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HighFDA (Devices)··2018-10-10
B. Braun Medical Recalls CE18HKCD Epidural Tray Connectors
B. Braun Medical is recalling CE18HKCD epidural tray connectors because they may not stay closed, leading to leakage or disconnection.
Product
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 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 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…
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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…
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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…
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