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Credits
Manufacturers
B. Braun Medical, Inc.
Manufacturer Address
B. Braun Medical, Inc., 901 Marcon Blvd, Allentown PA 18109-9512
Manufacturer Parent Company (2017)
Ludwig G. Braun Gmbh U. Co. Kg
Source
USFDA
48 Events
Recall of 7F Locking Tearaway Introducers
Recall of DStat Dry Hemostatic Bandage
Recall of Device Recall B. Braun Stopcock Extension Set
Recall of Device Recall B. Braun SAFSITE Injection Sites and IV Sets
Recall of Device Recall B. Braun
Recall of WHIN Infusion Set
Recall of NonVented Dispensing Pin
Recall of NonVented Dispensing Pin
Recall of B. Braun AccuFio 100ML/H 100ML Elastomeric Infusion Device
Recall of Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer
Recall of Device Recall B Braun 9F (O/S) Locking Tearaway Introducers
Recall of Right Heart Catheter Product Line: || Catalog Number 608055-------------827D1006I 4P BBM RMM Cath.
Recall of Right Heart Catheter Product Line: || Catalog Number 608054------------827D1006I 4P BBM RMM Cath.
Recall of Right Heart Catheter Product Line: || Catalog Number 604315-------------406-1H-018 426D1009I18PP.
Recall of Right Heart Catheter Product Line: || Catalog Number 604264-------------427D1006I Round Molded Manifold.
Recall of Right Heart Catheter Product Line: || Catalog Number 604239-------------426D1009I.
Recall of Right Heart Catheter Product Line: || Catalog Number 604165-------------T047-04 0427D1022I.
Recall of Right Heart Catheter Product Line: || Catalog Number 604103-------------T047(97) 427D4036I.
Recall of Right Heart Catheter Product Line: || Catalog Number 604100-----------T147-03 A427D1014 KANI 25PP.
Recall of Right Heart Catheter Product Line: || Catalog Number 604057---------------T147 A427D1014KANI
Recall of Right Heart Catheter Product Line: || Catalog Number 604037------T047-02 0427D10061.
Recall of Right Heart Catheter Product Line: || Catalog Number 604028------------T047(90) 427D1022I.
Recall of Right Heart Catheter Product Line: || Catalog Number 604025------------T046-02 0426D1009I RMM.
Recall of Right Heart Catheter Product Line: || Catalog Number 604000------417D1006I.
Recall of Right Heart Catheter Product Line: || Catalog Number 601293------------WP1107S Monitory Wedge Press.
Recall of Right Heart Catheter Product Line: || Catalog Number 601285-----WP11055 Wedge Press Cath.
Recall of Right Heart Catheter Product Line: || Catalog Number 601276 ----WP1107 Wedge Press Cath.
Recall of Right Heart Catheter Product Line: || Catalog Number 601272------WP1106 Wedge Press Cath.
Recall of Right Heart Catheter Product Line: || Catalog Number 601261-----WP605P Wedge Press Cath.
Recall of Right Heart Catheter Product Line: || Catalog Number 601258----WP604P Wedge Press Cath.
Recall of Right Heart Catheter Product Line: || Catalog Number 601129-----5011094 0106 x 1007BBMWS.
Recall of Device Recall Spinal Trays
Recall of Device Recall Spinal Trays
Recall of Device Recall Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter
Recall of Device Recall Contiplex Nerve Block Tray
Recall of Device Recall Pain Management Tray
Recall of Device Recall Customer Epidural Anesthesia Tray
Recall of Device Recall Spinal & Epidural Anesthesia Tray
Recall of Device Recall PENCAN Spinal Anesthesia Tray
Recall of Device Recall Perifix FX Epidural Anesthesia Tray
Recall of Device Recall Perifix Epidural AnesthesiaTray
Recall of Device Recall Pencan Spinal Needle Tray
Recall of Device Recall Perifix Single Dose Epidural Anesthesia Tray
Recall of Device Recall Perifix Continuous Epidural Anesthesia Tray
Recall of Device Recall Sterile IV Start Kit
Recall of Device Recall Custom Spinal Anesthesia Tray
Recall of Device Recall Pain Control Trays
Recall of Device Recall Various B. Braun pain control convenience trays
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46 devices in the database
7F Locking Tearaway Introducers
Model / Serial
Lot numbers 60710907 and 60710908
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
The product was shipped to two consignees that repack the product into their own kits.
Product Description
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
Model / Serial
Lot numbers 301323A and 301393
Product Classification
General and Plastic Surgery Devices
Device Class
Unclassified
Implanted device?
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.
Product Description
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Device Recall B. Braun Stopcock Extension Set
Model / Serial
Product codes: 473547 and 473549 lot #s and expiration dates: 61356774, 1/31/2019; 61362114, 2/28/2019; and 61367665, 3/31/2019.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
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.
Product Description
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
Model / Serial
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.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution.
Product Description
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
Model / Serial
Catalog #CT-2000-100lots 3H0125F151 and 3H0225F151, expiration 7/2018.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution one importer/wholesale distributor in MO.
Product Description
B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML || Generally used for delivery of antibiotic and local anesthesia medications.
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2 manufacturers with a similar name
Learn more about the data
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B. Braun Medical, Inc.
Manufacturer Address
B. Braun Medical, Inc., 901 Marcon Blvd, Suite 200, Allentown PA 18109-9512
Source
USFDA
B. Braun Medical, Inc.
Manufacturer Address
B. Braun Medical, Inc., 901 Marcon Boulevard, Allentown PA 18109-9512
Manufacturer Parent Company (2017)
Ludwig G. Braun Gmbh U. Co. Kg
Source
USFDA
Language
English
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