urgent market withdrawal noticeb. braun medical pa usa b i braun api from spain lot exp heparin...

B. Braun Medical Inc. URGENT MARKET WITHDRAWAL NOTICE Affected Product and Distribution Information: Item Description Reason for Market Withdrawal: Risk to Health: Actions to be taken by the Customer/User:

Upload: others

Post on 26-Nov-2020

0 views

Category:

Documents

0 download

Report

Download

Embed Size (px):

TRANSCRIPT

B. Braun Medical Inc.

URGENT MARKET WITHDRAWAL NOTICE

Affected Product and Distribution Information:

Item Description

Reason for Market Withdrawal:

Risk to Health:

Actions to be taken by the Customer/User:

Page 2: URGENT MARKET WITHDRAWAL NOTICEB. Braun Medical PA USA B I BRAUN API from Spain LOT EXP HEPARIN SODIUM 20,000 units 500 mL (40 USP units per ml.) in 5% Dextrose Injection 500 rnL 0264-9567-10

http://www.fda.gov/medwatch/report.htm

http://www.fda.gov/MedWatch/getforms.htm

Page 3: URGENT MARKET WITHDRAWAL NOTICEB. Braun Medical PA USA B I BRAUN API from Spain LOT EXP HEPARIN SODIUM 20,000 units 500 mL (40 USP units per ml.) in 5% Dextrose Injection 500 rnL 0264-9567-10

B. Braun Medical Inc.

Page 4: URGENT MARKET WITHDRAWAL NOTICEB. Braun Medical PA USA B I BRAUN API from Spain LOT EXP HEPARIN SODIUM 20,000 units 500 mL (40 USP units per ml.) in 5% Dextrose Injection 500 rnL 0264-9567-10

B. Braun Medical Inc.

Page 5: URGENT MARKET WITHDRAWAL NOTICEB. Braun Medical PA USA B I BRAUN API from Spain LOT EXP HEPARIN SODIUM 20,000 units 500 mL (40 USP units per ml.) in 5% Dextrose Injection 500 rnL 0264-9567-10

B. Braun Medical Inc.

Page 6: URGENT MARKET WITHDRAWAL NOTICEB. Braun Medical PA USA B I BRAUN API from Spain LOT EXP HEPARIN SODIUM 20,000 units 500 mL (40 USP units per ml.) in 5% Dextrose Injection 500 rnL 0264-9567-10

B. Braun Medical Inc.

Page 7: URGENT MARKET WITHDRAWAL NOTICEB. Braun Medical PA USA B I BRAUN API from Spain LOT EXP HEPARIN SODIUM 20,000 units 500 mL (40 USP units per ml.) in 5% Dextrose Injection 500 rnL 0264-9567-10

B. Braun Medical Inc.

Item: P5671 (NDC: 0264-9567-10) Item: P5771 (NDC: 0264-9577-10) Item: P5872 (NDC: 0264-9587-20)

Page 8: URGENT MARKET WITHDRAWAL NOTICEB. Braun Medical PA USA B I BRAUN API from Spain LOT EXP HEPARIN SODIUM 20,000 units 500 mL (40 USP units per ml.) in 5% Dextrose Injection 500 rnL 0264-9567-10

B. Braun Medical Inc.

MARKET WITHDRAWAL ACKNOWLEDGEMENT

INVENTORY OF MARKET WITHDRAWALED PRODUCT

Product

Catalog No.

NDC Number Product

Description

Batch No. of UNITS

(out of case)

on Hand

No. of CASES

(unopened

cases) on

HAND

Total Units

to Return

Page 9: URGENT MARKET WITHDRAWAL NOTICEB. Braun Medical PA USA B I BRAUN API from Spain LOT EXP HEPARIN SODIUM 20,000 units 500 mL (40 USP units per ml.) in 5% Dextrose Injection 500 rnL 0264-9567-10

B. Braun Medical Inc.

DISTRIBUTOR INFORMATION USER FACILITY OR OTHER INFORMATION

CONTACT INFO & SIGNATURE OF INDIVIDUAL COMPLETING FORM

Density = Massm Volumev Units g/ml, g/cm 3, g/cc Remember 1 ml = 1 cm 3 = 1 cc

Enzymatic Assay of L-PHENYLALANINE DEHYDROGENASE (EC 1… 1.4.1.20L... · (EC 1.4.1.20) CALCULATIONS: (continued) units/ml enzyme Units/mg protein = mg protein/ml enzyme UNIT DEFINITION:

Braun Stein

Quantitative Analysis Sample Report...Quantitative Analysis Sample Report 2.433 Final Conc 11.8235 Units ng/ml 6.9724 Units ng/ml Data File CMAMBlk_01.d Sample Name Blank-1 Compound

INTRAVENOUS INFUSION (STREPTOKINASE) 1...of SK varying from 2,000 units to 10 units were con-tained in 0.1 ml. of gelatin buffer. One tenth of one ml. of each dilution was then dispensed

Chris Braun

Series 9 - Braun · Braun Infolines Lignes d’assistance Braun Thank you for purchasing a Braun product. We hope you are completely satisfied with your new Braun shaver. If you have

Syringes & Needles - B. Braun...(non-sterile) 3 ml 0.1 ml centric/luer 9200210 5 ml 0.2 ml centric 9200510 10 ml 0.5 ml centric 9201010 20 ml 1 ml centric 9202010 9 new! Blue plunger

100 units/ml solution for injection in pre-filled pen

Braun Charles__1527__scanned

Catalog Braun

PLEASE READ THESE INSTRUCTIONS BEFORE USE - Lilly · Instructions for Use HUMALOG® ®200 units/mL KwikPen insulin lispro (200 units/mL, 3 mL pen) PLEASE READ THESE INSTRUCTIONS BEFORE

STUDIES ON PROTECTIVE ANTIGEN ANTHRACISPRODUCED · Activities ofrepresentative crude antigen preparations CultureFiltrate (NH4)2SO4 Precipitate Recovery I units/mi ml units/ml % 9.30

RMP V03 Oct14 - HPRA · After-dilution; Paracetamol B. Braun can be diluted in 9 mg/ml (0.9%) sodium chloride solution for infusion or 50 mg/ml (5%) glucose solution for infusion

braun prize

Metric System Calculations - RN.com Med Calc plus...Patient is receiving 1000 units in 10 mL at 100 mL/hr. How many units is the patient receiving per hour. 1. Write a fraction to

Brochure Braun

Braun Venus

Eli Lilly and Company HUMULIN N - insulin human injection ......Injectable suspension 100 units per mL (U-100) available as 10 mL vials, 3 mL vials, and 3 mL HUMULIN N KwikPen (prefilled)

AUDIT MicroControls, Inc€¦ · Analyte Units Typical Ranges Estradiol pg/mL 20 - 3,000 FSH mIU/mL 0.5 - 200 hCG mIU/mL 5 - 1,000 LH mIU/mL 0.25 - 200 Progesterone ng/mL 0.5 - 60

MICHELLE BRAUN, ON BEHALF OF : IN THE SUPERIOR COURT OF ... · Michelle Braun (“Braun”), Dolores Hummel (“Hummel”) (we refer to Braun and Hummel collectively as “Appellees”),

Braun 1997

medialibrarycdn.propertysolutions.com · 2013-12-20 · portfolio of affordable units receiving ... Milford, Ml Bloomington, IN Boston, MA Cumberland Foreside, TOTAL NUMBER OF UNITS

NewInsulinGlargine300Units/mL Versus Glargine 100 Units/mL …care.diabetesjournals.org/content/diacare/37/10/2755.full.pdf · Long-acting (basal) insulin analogs have contributedsigniﬁcantlytothemanage-ment

New Insulin Glargine 300 Units/mL Versus Glargine 100 Units/mL in People With Type 2 Diabetes Using Basal and Mealtime Insulin: Glucose Control and Hypoglycemia

FOR THE DISTRICT OF DELAWARE BRAUN BRAUN … · FOR THE DISTRICT OF DELAWARE B. BRAUN MELSUNGEN AG, B. BRAUN MEDICAL INDUSTRIES SDN. BHD. and B. BRAUN MEDICAL, INC., Plaintiffs; V

Bottle Top Horizontal 2.5 mL Electrophoresis 5.0 mL Units ... · ±% ±mL CV ±% ±mL 0.25-2.5 0.05 0.6 0.015 0.2 0.005 0.5-5 0.1 0.5 0.025 0.1 0.005 1-10 0.2 0.5 0.050 0.1 0.010

braun multiquick

Bert Niesters - National Institute for Biological Standards and · PDF fileCopies/ml Genome equivalents/ml Mega-equivalents/ml Log10 copies/ml SuperQuant copies/ml International units/ml

Drug Information Update › sites › default › files... · Drugs oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma

Bacterial lacL Gene as a Highly Sensitive Marker to Detect ... › content › canres › ... · co's modified Eagle's medium with 250 units/ml penicillin, 250 units/ ml streptomycin

Braun thermoscan

BRAUN Hamburg to launch new label „BRAUN HAMBURG

Braun Catalog

Braun 3710