Important Product Updates

Important Product Updates

Product Updates

Customer communications provide important updates about our products and therapies. Customer letters on this page have been mailed directly to customers affected by the specific updates and in some situations include reply forms for customers to return to us. If you have questions or want more information, contact us at:

Customer Service

Hospital Products & Renal

Toll-Free: 1-888-229-0001 (1-224-948-1856)

RENAL (Home Patients Only)

Toll-Free: 1-800-284-4060 (1-224-948-1840) 

 

Date Product Category Reference
9/24/24 Automated Compounding Device Inlets (disposable inlet) used with the ExactaMix and ExactaMix Pro Urgent Medical Device Correction

Important Safety Information regarding the potential presence of particulate matter within the inlet primary packaging components, including within the sterile fluid path tubing

FDA Announcement

3/9/23 Life2000 Ventilation System Urgent Medical Device Correction

Important Safety Information regarding the potential for patient oxygen desaturation events that can occur when Life2000 system is connected with a third-party oxygen concentrator

Press Release

10/21/22 WatchCare Incontinence Management System Urgent Medical Device Correction

Important Safety Information regarding the potential for radio frequency interference with other devices near beds that are installed with WatchCare System

Press Release

8/9/2022 Clearlink Basic Solution Set with Duovent Urgent Medical Device Correction

Important Safety Information regarding the potential risk of leak complications of Clearlink Solution Set 2R8403

Urgent Medical Device Correction

6/22/2022 Abacus Order Entry and Calculation Software Urgent Medical Device Correction

Important Safety Information regarding the potential risk of medication error when using certain product codes for the Abacus Order Entry and Calculation Software

Urgent Medical Device Correction

6/1/2022 Volara with In-Line VENTILATOR Adaptor Urgent Medical Device Correction

Important Safety Information regarding possible risk of oxygen desaturation or barotrauma in the home care environment when using Volara in line with a ventilator. 

Press Release

12/29/2021 Spectrum IQ Infusion System with Dose IQ Safety Software SIGMA Spectrum Infusion System (V8 Platform) Urgent Safety Communication

Important Safety Information regarding upstream occlusion alarms for all Spectrum IQ and Spectrum V8 infusion pumps

Urgent Safety Communication

08/02/2021 Spectrum IQ Infusion System with Dose IQ Safety Software Urgent Device Correction

Important Safety Information regarding best practices for customer-initiated IT network updates

Urgent Device Correction

07/07/21 Dose IQ Safety Software used with Spectrum IQ Infusion Pump Urgent Device Correction

Important Safety Information regarding Dose IQ Safety Software desktop application version 9.0.x

Urgent Device Correction

08/28/2020

SIGMA SPECTRUM Infusion System (V6 Platform)

SIGMA SPECTRUM Infusion System (V8 Platform)

Spectrum IQ Infusion System with Dose IQ Safety Software

Urgent Device Correction

Urgent Device Correction regarding cleaning practices

Urgent Device Correction
04/01/2020

SIGMA SPECTRUM Infusion System (V6 Platform)

SIGMA SPECTRUM Infusion System (V8 Platform)

Spectrum IQ Infusion System with Dose IQ Safety Software

Safety Alert

Safety Alert regarding cleaning practices

Safety Alert

05/02/2019 Heparin Sodium BP 2,000 IU/L in 0.9% w/v Sodium Chloride IV Infusion (VIAFLEX container), 500mL / 1,000mL Important Product Info

Temporary importation of intravenous drug products to address drug shortages

Ref. DHCP Letter

06/20/2018

INFUVITE ADULT Multiple Vitamins Injection, 5mL Important Product Info

Labeling error

Ref. DHCP Letter

05/23/2018

INFUVITE ADULT Multiple Vitamins Injection, 5mL

Important Product Info Labeling error 

Ref. DHCP Letter
04/05/2018

0.9% Sodium Chloride Injection, BP, MINI-BAG Plus (VIAFLEX Container), 50mL / 100mL

0.9% Sodium Chloride Injection, BP,(VIAFLO Container), 50mL / 100mL

5% Glucose Injection, BP*, (VIAFLO Container), 50mL / 100mL

Metronidazole Injection 500mg Isotonic Saline (VIAFLO Container), 100mL

BP = British Pharmacopoeia
* dextrose monohydrate (or glucose monohydrate) = anhydrous dextrose (or anhydrous glucose)

Important Product Info Temporary importation of intravenous drug products to address drug shortages

Ref. DHCP Letter
01/31/2018

0.9% Sodium Chloride Injection
(VIAFLEX Container), 250mL / 500mL / 1,000mL

Important Product Info Temporary importation of intravenous drug products to address drug shortages

Ref. DHCP Letter
01/15/2018

0.9% Sodium Chloride Injection
(VIAFLEX Container), 100mL

5% Dextrose Injection 
(VIAFLEX Container), 100 mL

Important Product Info Temporary importation of intravenous drug products to address drug shortages

Ref. DHCP Letter
11/30/2017

Primene 10% Solution for Infusion
(Glass Container), 250 mL

Important Product Info Temporary importation of intravenous drug products to address drug shortages

Ref. DHCP Letter
11/08/2017

CLINIMIX N9G15E-Solution for Infusion
5.5% Amino Acids with Electrolytes (500 mL) and
Glucose 15% with Calcium (500 mL) for a final mixture
2.75% Amino Acid in 7.5% Glucose with Electrolytes

CLINIMIX N9G20E-Solution for Infusion
5.5% Amino Acids with Electrolytes (500 mL) and
Glucose 20% with Calcium (500 mL) for a final mixture
of 2.75% Amino Acid in 10% Glucose with Electrolytes

CLINIMIX N14G30E-Solution for Infusion
8.5% Amino Acids with Electrolytes (1000 mL) and
Glucose 30% with Calcium (1000 mL) for a final mixture
of 4.25% Amino Acid in 15% Glucose with Electrolytes

Important Product Info Temporary importation of intravenous drug products to address drug shortages

Ref. DHCP Letter
11/03/2017

SYNTHAMIN 17 without Electrolytes
10% Amino Acid Intravenous Infusion, 3000 mL

Important Product Info Temporary importation of intravenous drug products to address drug shortages

Ref. DHCP Letter
10/31/2017

Heparin Sodium BP 2,000 IU/L in 0.9% w/v
Sodium Chloride IV Infusion in VIAFLEX
container (1,000 units / 500 mL)

Heparin Sodium BP 2,000 IU/L in 0.9% w/v
Sodium Chloride IV Infusion in VIAFLEX
container (2,000 units / 1,000 mL)

Important Product Info Temporary importation of intravenous drug products to address drug shortages

Ref. DHCP Letter
10/27/2017

Supply of intravenous (IV) solutions in the United States

Important Product Info Update on Puerto Rico Recovery

Ref. DHCP Letter
10/20/2017

0.9% Sodium Chloride in Water for Injection BAXTER in VIAFLEX plastic container, 50mL, 100mL

5% Dextrose in Water for Injection BAXTER in VIAFLEX plastic container, 50mL, 100mL

Important Product Info Temporary importation of intravenous drug products to address drug shortages

Ref. DHCP Letter
10/16/2017

0.9% Sodium Chloride Injection USP in VIAFLEX Container, 50mL, 100mL, 250mL, 500mL, 1000mL

5% Dextrose Injection USP in VIAFLEX Container, 50mL, 100mL

0.9% Sodium Chloride Injection USP in MINI-BAG Plus Container, 50mL, 100mL

5% Dextrose Injection USP in MINI-BAG Plus Container, 50mL, 100mL

Lidocaine Hydrochloride 0.4% and 5% Dextrose Injection USP (4mg/mL) in VIAFLEX Container, 1g/250mL, 2g/500mL

Important Product Info Temporary importation of intravenous drug products to address drug shortages

Ref. DHCP Letter
10/09/2017

Sodium Chloride 0.9% Intravenous Infusion in VIAFLEX Container, 100mL, 50mL


Glucose 5% Intravenous Infusion* in VIAFLEX Container, 100mL, 50mL
Important Product Info Temporary importation of intravenous drug products to address drug shortages

Ref. DHCP Letter
10/09/2017

Sodium Chloride 0.9% w/v Intravenous Infusion, BP, MINI-BAG Plus in VIAFLEX plastic container, 50mL, 100mL

Sodium Chloride 0.9% w/v Intravenous Infusion, BP, in VIAFW container, 50mL, 100mL

Glucose 5% w/v Intravenous Infusion BP* in VlAFLO container, 50mL, 100mL

Metronidazole Injection 500mg Isotonic Saline in VIAFLO container, 100mL

Important Product Info Temporary importation of intravenous drug products to address drug shortages

Ref. DHCP Letter
10/05/2017 INTALIPID 20% IV Fat Emulsion, 100 mL Urgent Product Recall Customer Reference Letter FA-2017-032

Press Release