B Braun Medical Inc
Irvine, CA, US
B. BRAUN MEDICAL INC. appears in FDA device records in Irvine, CA. FDA records list 2 510(k) clearances between and , no PMA records and 9 registered establishments. As of , FDA records show 513 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
4 namesFDA records resolved to B Braun Medical Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- B. BRAUN US DEVICE MANUFACTURING LLCregistration
- B. BRAUN US PHARMACEUTICAL MANUFACTURING LLCregistration
- B.Braun Medical S.A.S.enforcement report, recall
- Braun,B Medical Increcall
510(k) clearance history
FDA records hold 2 510(k) clearances for B Braun Medical Inc between 1997 and 1998. The busiest year on record is 1997, with 1. The most recent is 1998, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1998 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9612452 | 3002806713 | B. BRAUN MEDICAL | 30 AVENUE DES TEMPS MODERNES, CHASSENEUIL-DU-POITOU Vienne 86360 FR | 2026 | |
| 8031007 | 5637 | B. BRAUN MEDICAL AG | HAUPTSTRASSE 39, ESCHOLZMATT Luzern CH-6182 CH | 2026 | |
| 2521402 | 2521402 | B. BRAUN MEDICAL INC. | 824 12th Ave, BETHLEHEM, PA 18018 US | 2026 | and 33 more, listed in full below |
| 3013764800 | 3013764800 | B. BRAUN MEDICAL INC. | 861 Marcon Blvd., Allentown, PA 18109 US | 2026 | and 52 more, listed in full below |
| 9680474 | 3007655970 | B. BRAUN MEDICAL, LTD. | DELI-KULHATAR UT 2-4, GYONGYOS Heves H-3200 HU | 2026 | |
| 2523676 | 2523676 | B. BRAUN US DEVICE MANUFACTURING LLC | 901 Marcon Blvd, ALLENTOWN, PA 18109 US | 2026 | and 47 more, listed in full below |
| 2021236 | 2021236 | B. BRAUN US PHARMACEUTICAL MANUFACTURING LLC | 2525 MCGAW AVE., IRVINE, CA 92614 US | 2026 | |
| 3007120504 | 3007120504 | B. Braun Medical AG | Seesatz 17, Sempach Luzern CH-6204 CH | 2026 | |
| 3005694677 | 3005694677 | B. Braun Medical S.A. | Route de la Sorge 9, Crissier Vaud CH-1023 CH | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KGZAccessories, Catheter
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- EYIAdaptor, Ureteral Catheter
- CAZAnesthesia Conduction Kit
- HRXArthroscope
- KDQBottle, Collection, Vacuum
- BSOCatheter, Conduction, Anesthetic
- DYGCatheter, Flow Directed
- JCYCatheter, Infusion
- DQOCatheter, Intravascular, Diagnostic
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- GBXCatheter, Irrigation
- DQYCatheter, Percutaneous
- KPEContainer, I.V.
- FMHContainer, Specimen, Sterile
- KMKDevice, Intravascular Catheter Securement
- KYGDevice, Irrigation, Ocular Surgery
- KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- LRJDisinfectant, Medical Devices
- KYXDispenser, Liquid Medication
- KKXDrape, Surgical, Antimicrobial
- FRODressing, Wound, Drug
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- DTKFilter, Intravascular, Cardiovascular
- LRSI.V. Start Kit
- DXTInjector And Syringe, Angiographic
- DYBIntroducer, Catheter
- GCJLaparoscope, General & Plastic Surgery
- FMJManometer, Spinal-Fluid
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- GAANeedle, Aspiration And Injection, Disposable
- GCBNeedle, Catheter
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- FMINeedle, Hypodermic, Single Lumen
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
- FRNPump, Infusion
- LKKPump, Infusion, Implanted, Programmable
- FPASet, Administration, Intravascular
- LHISet, I.V. Fluid Transfer
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve
- FOXStand, Infusion
- BXNStimulator, Nerve, Battery-Powered
- FMGStopcock, I.V. Set
- DWQStripper, Vein, External
- FIPSubsystem, Water Purification
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- KYZSyringe, Irrigating (Non Dental)
- FMFSyringe, Piston
- IWJSystem, Applicator, Radionuclide, Manual
- FKQSystem, Dialysate Delivery, Central Multiple Patient
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- LJHSystem, Irrigation, Urological
- KDNSystem, Perfusion, Kidney
- IZISystem, X-Ray, Angiographic
- LCJTissue Expander And Accessories
- ITXTransducer, Ultrasonic, Diagnostic
- BYYTube, Aspirating, Flexible, Connecting
- GAZTubing, Noninvasive
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 513| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3089-2026 | Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025 | Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label. | Class II | Open, Classified | |
| Z-2278-2026 | Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C 20061890 (560074), SSK S C H (560214), SSK BJC H S (ORIGINAL CUST) (560272), SSK CA P M C (ORIGINAL CUST) (560327), SSK T M H (560394), SSK S O 20070208 (560428), SSK L G H (ORIGINAL CUST) (560462), SSK H M H (560465), SSK BUPIVACAINE TRAY 2068824 (560476), SSK K F H (560497), SSK T J U H (560513), SSK O M C (560521), SSK CUSTOM SPINAL TRAY (560523), SSK O R M C (560533), SSK B S H S 20115122 (560538), SSK M M (560572), SSK M S 27GA PENCAN SPINAL TRAY (560580), SSK S T H & C (560584), SSK U C (560587), SSK P25BKG (560603), SSK P24BKG (560606), SSK S25BKG (560607), SSK M C - BUPIVACAINE TRAY (560609), SSK T M C (560613), SSK PENCIL POINT SPINAL TRAY (560619), SSK E O & S H-SPINAL (560621), SSK BSW SPINAL TRAY (560628), SSK M C OB DEPT - SPINAL (560645), SSK B H M (560646), SSK M G M C (560647), SSK S M H (560648), SSK H H S (560660), O S U M C SPINAL TRAY SSK (560667), A M C, SSK (560670), S B H - SPINAL TRAY SSK (560672); | These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection. | Class I | Open, Classified | |
| Z-2277-2026 | Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333201); Spinocan 25 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333211); Spinocan 22 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333231) | These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection. | Class I | Open, Classified | |
| Z-2276-2026 | Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867); 25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862); GOVP24BK 24G PENCAN TRAY W/ BUP & DEXTROS (332607); P24BK 24G PENCAN TRAY W/BUP & DEXTROSE (333868); P25BKAY PENCAN SPINAL TRAY (333865); P27BK PENCAN SPINAL W/BUPIVAC (333871); P25BK SPINAL TRAY (333851) | These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection. | Class I | Open, Classified | |
| Z-1803-2026 | B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705. | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. | Class I | Open, Classified | |
| Z-1802-2026 | B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705. | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. | Class I | Open, Classified | |
| Z-1801-2026 | B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L. | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. | Class I | Open, Classified | |
| Z-1800-2026 | B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA. | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. | Class I | Open, Classified | |
| Z-1799-2026 | B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096 | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. | Class I | Open, Classified | |
| Z-1798-2026 | B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A. | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. | Class I | Open, Classified | |
| Z-1483-2026 | Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. | Class II | Open, Classified | |
| Z-1482-2026 | Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. | Class II | Open, Classified | |
| Z-1481-2026 | Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. | Class II | Open, Classified | |
| Z-2270-2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog Number: 530134 Software Version: N/A Product Description: SESK UPMC DOUBLE CATHETER TRAY Component: No | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable. | Class II | Open, Classified | |
| Z-2269-2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Number: 555884 Software Version: N/A Product Description: CESK SHANDS JACKSONVILLE 20055717 Component: No | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable. | Class II | Open, Classified | |
| Z-2268-2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: 552126 Software Version: N/A Product Description: CESK RIVERSIDE HEALTH SYSTEM Component: No | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable. | Class II | Open, Classified | |
| Z-2267-2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number: 530184 Software Version: N/A Product Description: LYNDON B JOHNSON HOSPITAL SPINAL EPID Component: No | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable. | Class II | Open, Classified | |
| Z-2266-2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Number: 555498 Software Version: N/A Product Description: CESK HARRIS METHODIST Component: No | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable. | Class II | Open, Classified | |
| Z-2265-2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201 Software Version: N/A Product Description: NES1725KFXL SPINAL EPID CLOSED TIP CATH Component: No | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable. | Class II | Open, Classified | |
| Z-2264-2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog Number: 570246 Software Version: N/A Product Description: BPSK, BLOCKJOCKS TRAY Component: No | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable. | Class II | Open, Classified | |
| Z-2263-2026 | Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software Version: N/A Product Description: CESK NORTHSIDE ANESTHESIA TRAY Component: No | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable. | Class II | Open, Classified | |
| Z-0718-2026 | IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 110 IN.; Catalog Number: 490566. | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | Class II | Open, Classified | |
| Z-0717-2026 | IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 15DROPS/ML; Catalog Number: 490508. | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | Class II | Open, Classified | |
| Z-0716-2026 | Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK IV SET 15DR W/2 CARESITE FILTER; Catalog Number: 354214. | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | Class II | Open, Classified | |
| Z-0715-2026 | Vista set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. VISTA BASIC PUMP IV SET W/ 15 DROP/ML; Catalog Number: US9923F. | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain