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Crédits
Manufacturers
B. Braun Medical, Inc.
Adresse du fabricant
B. Braun Medical, Inc., 901 Marcon Blvd, Allentown PA 18109-9512
Société-mère du fabricant (2017)
Ludwig G. Braun Gmbh U. Co. Kg
Source
USFDA
48 Events
Rappel de 7F Locking Tearaway Introducers
Rappel de DStat Dry Hemostatic Bandage
Rappel de Device Recall B. Braun Stopcock Extension Set
Rappel de Device Recall B. Braun SAFSITE Injection Sites and IV Sets
Rappel de Device Recall B. Braun
Rappel de WHIN Infusion Set
Rappel de NonVented Dispensing Pin
Rappel de NonVented Dispensing Pin
Rappel de B. Braun AccuFio 100ML/H 100ML Elastomeric Infusion Device
Rappel de Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer
Rappel de Device Recall B Braun 9F (O/S) Locking Tearaway Introducers
Rappel de Right Heart Catheter Product Line: || Catalog Number 608055-------------827D1006I 4P BBM RMM Cath.
Rappel de Right Heart Catheter Product Line: || Catalog Number 608054------------827D1006I 4P BBM RMM Cath.
Rappel de Right Heart Catheter Product Line: || Catalog Number 604315-------------406-1H-018 426D1009I18PP.
Rappel de Right Heart Catheter Product Line: || Catalog Number 604264-------------427D1006I Round Molded Manifold.
Rappel de Right Heart Catheter Product Line: || Catalog Number 604239-------------426D1009I.
Rappel de Right Heart Catheter Product Line: || Catalog Number 604165-------------T047-04 0427D1022I.
Rappel de Right Heart Catheter Product Line: || Catalog Number 604103-------------T047(97) 427D4036I.
Rappel de Right Heart Catheter Product Line: || Catalog Number 604100-----------T147-03 A427D1014 KANI 25PP.
Rappel de Right Heart Catheter Product Line: || Catalog Number 604057---------------T147 A427D1014KANI
Rappel de Right Heart Catheter Product Line: || Catalog Number 604037------T047-02 0427D10061.
Rappel de Right Heart Catheter Product Line: || Catalog Number 604028------------T047(90) 427D1022I.
Rappel de Right Heart Catheter Product Line: || Catalog Number 604025------------T046-02 0426D1009I RMM.
Rappel de Right Heart Catheter Product Line: || Catalog Number 604000------417D1006I.
Rappel de Right Heart Catheter Product Line: || Catalog Number 601293------------WP1107S Monitory Wedge Press.
Rappel de Right Heart Catheter Product Line: || Catalog Number 601285-----WP11055 Wedge Press Cath.
Rappel de Right Heart Catheter Product Line: || Catalog Number 601276 ----WP1107 Wedge Press Cath.
Rappel de Right Heart Catheter Product Line: || Catalog Number 601272------WP1106 Wedge Press Cath.
Rappel de Right Heart Catheter Product Line: || Catalog Number 601261-----WP605P Wedge Press Cath.
Rappel de Right Heart Catheter Product Line: || Catalog Number 601258----WP604P Wedge Press Cath.
Rappel de Right Heart Catheter Product Line: || Catalog Number 601129-----5011094 0106 x 1007BBMWS.
Rappel de Device Recall Spinal Trays
Rappel de Device Recall Spinal Trays
Rappel de Device Recall Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter
Rappel de Device Recall Contiplex Nerve Block Tray
Rappel de Device Recall Pain Management Tray
Rappel de Device Recall Customer Epidural Anesthesia Tray
Rappel de Device Recall Spinal & Epidural Anesthesia Tray
Rappel de Device Recall PENCAN Spinal Anesthesia Tray
Rappel de Device Recall Perifix FX Epidural Anesthesia Tray
Rappel de Device Recall Perifix Epidural AnesthesiaTray
Rappel de Device Recall Pencan Spinal Needle Tray
Rappel de Device Recall Perifix Single Dose Epidural Anesthesia Tray
Rappel de Device Recall Perifix Continuous Epidural Anesthesia Tray
Rappel de Device Recall Sterile IV Start Kit
Rappel de Device Recall Custom Spinal Anesthesia Tray
Rappel de Device Recall Pain Control Trays
Rappel de Device Recall Various B. Braun pain control convenience trays
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46 dispositifs dans la base de données
7F Locking Tearaway Introducers
Modèle / numéro de série
Lot numbers 60710907 and 60710908
Classification du dispositif
Cardiovascular Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
The product was shipped to two consignees that repack the product into their own kits.
Description du dispositif
7F Locking Tearaway Introducers non-sterile. Part number 614006. The product is packaged as 50 units per pouch, 2 pouches per carton.
DStat Dry Hemostatic Bandage
Modèle / numéro de série
Lot numbers 301323A and 301393
Classification du dispositif
General and Plastic Surgery Devices
Classe de dispositif
Unclassified
Dispositif implanté ?
No
Distribution
The product was shipped to hospitals/medical facilities in AZ, CA, FL, GA, IL, MA, MN, MO, NY, NJ, OH, PA, TN, TX, and WI.
Description du dispositif
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Device Recall B. Braun Stopcock Extension Set
Modèle / numéro de série
Product codes: 473547 and 473549 lot #s and expiration dates: 61356774, 1/31/2019; 61362114, 2/28/2019; and 61367665, 3/31/2019.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
USA (nationwide) including the states of PA, IL, NC, FL, IL, CA, CO, NE, LA, NC, LA, VA, TN, NE, TX, and KS.
Description du dispositif
STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
Device Recall B. Braun SAFSITE Injection Sites and IV Sets
Modèle / numéro de série
Catalog #351559: batch #s 0061339694, exp. 9/30/2018, 0061338909,exp. 9/30/2018, 0061333582, exp. 8/31/2018; catalog # 352016, batch # 0061326956, exp. 10/31/2018; catalog # 352079, batch #0061333591, exp. 8/31/2018; catalog #352448, batch # 0061334116, exp.9/30/2018; catalog #473017, batch #0061332459, exp. 8/31/2018; catalog # 473017, batch #061335025, exp. 9/30/2018; catalog #473309, batch #s 0061343285, exp. 10/31/2018; calatog #473309, lot #061329867, exp. 9/30/2018, 0061339741, exp. 9/30/2018, 0061333662, exp. 8/31/2018; catalog #474563, batch #s 0061338023, exp. 10/31/2018, 0061333063, exp. 8/31/2018; catalog #490028, batch # 0061324733, exp. 8/31/2018; catalog #490213, batch #s 0061330803, 9/30/2015, 0061345558, exp. 11/30/2015; catalog # SS3140, batch # 0061339123, exp. 9/30/2015; catalog #7B0110, batch #s61315790, 61315791, 61317168, 61317170, 61318428, 61318430, 61318850, 61322303,61326405, 61327038, 61330199, 61331458, all NonSterile, No Expiration Date; catalog # 7B3179, batch #s 61313363, 61314531, 61314532, 61314535, 61330221, all NonSterile, No Expiration Date; catalog #7B3240, batch #s 61324238, exp. 8/31/2018; 61329535, exp. 9/30/2018; 61336490, exp. 7/31/2018; catalog # S5401118N, batch #0061335969, Bulk Non-Sterile, No Expiration Date; and catalog #S5401150N, batch #61326267, NonSterile; No Expiration Date.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Nationwide Distribution.
Description du dispositif
SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. || A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Device Recall B. Braun
Modèle / numéro de série
Catalog #CT-2000-100lots 3H0125F151 and 3H0225F151, expiration 7/2018.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
US Distribution one importer/wholesale distributor in MO.
Description du dispositif
B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML || Generally used for delivery of antibiotic and local anesthesia medications.
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B. Braun Medical, Inc.
Adresse du fabricant
B. Braun Medical, Inc., 901 Marcon Blvd, Suite 200, Allentown PA 18109-9512
Source
USFDA
B. Braun Medical, Inc.
Adresse du fabricant
B. Braun Medical, Inc., 901 Marcon Boulevard, Allentown PA 18109-9512
Société-mère du fabricant (2017)
Ludwig G. Braun Gmbh U. Co. Kg
Source
USFDA
Language
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