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

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Hospital Products & Renal

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