FRANKLIN LAKES, N.J.,
Aug. 20, 2020 /PRNewswire/ -- BD
(Becton, Dickinson and Company) (NYSE: BDX), a leading global
medical technology company, today provided an update on a
previously announced voluntary recall of the BD Alaris™ System.
Three of the situations described in this recall, which BD
announced on June 30, 2020, have been
designated as Class I recalls by the U.S. Food and Drug
Administration (FDA), which means that there is a reasonable
probability that the use of the product will cause serious adverse
health consequences or death. One of the situations was
designated as a Class II recall, which means use of the product may
cause temporary or medically reversible adverse health consequences
or where the probability of serious adverse health consequences is
remote.
This FDA classification does not change the guidance BD
provided in the company's June recall announcement to
customers.
BD initiated the voluntary recall to notify customers of the
potential for four hardware situations that may result in the
infusion pump not operating as expected. BD has provided
instructions to correct and/or mitigate the situations. The four
situations include:
- Damaged Inter-Unit Interface (IUI) Connectors (Situation 1 –
Class I)
- Broken elements on Alaris™ Pump Module platen (Situation 2 –
Class I)
- Improperly secured PC unit Battery (Situation 3 – Class I)
- Dim LED Segment(s) on the Alaris™ modules (Situation 4 – Class
II)
Customers should review and follow the instructions in the
recall letter:
www.bd.com/en-us/support/recall-notifications/recall-notification-for-alaris-system-infusion-pump-hardware
Affected Products
Product
Name
|
Situation
1
|
Situation
2
|
Situation
3*
|
Situation
4
|
Alaris™ System PC
Unit Model 8000
|
X
|
|
X
|
|
Alaris™ System PC
Unit Model 8015
|
X
|
|
X
|
X
|
Alaris™ Pump Module
Model 8100
|
X
|
X
|
|
X
|
Alaris™ Syringe
Module Model 8110
|
X
|
|
|
X
|
Alaris™ PCA Module
Model 8120
|
X
|
|
|
X
|
Alaris™ EtCO2 Module
Model 8300
|
X
|
|
|
X
|
Alaris™ SpO2 Module
Model 8210 and Model 8220
|
X
|
|
|
X
|
Alaris™ Auto ID
Module Model 8600
|
X
|
|
|
|
|
*Note: Since
Situation 3 affects the batteries of the PC Units, it may cause
power loss to any attached module.
|
Note that some affected devices may be branded under the
CareFusion name. Customer inquiries related to this action should
be addressed to BD's Recall Support Center at 888-562-6018 or
SupportCenter@bd.com.
FDA MedWatch Reporting
Adverse reactions/events experienced with the use of either of
these products should also be reported to the FDA's MedWatch
Program by:
- Web: MedWatch website at www.fda.gov/medwatch
- Phone: 1-800-FDA-1088
- Fax: 1-800-FDA-0178
- Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
About BD
BD is one of the largest global medical technology companies in the
world and is advancing the world of health by improving medical
discovery, diagnostics and the delivery of care. The company
supports the heroes on the frontlines of health care by developing
innovative technology, services and solutions that help advance
both clinical therapy for patients and clinical process for health
care providers. BD and its 65,000 employees have a passion and
commitment to help enhance the safety and efficiency of clinicians'
care delivery process, enable laboratory scientists to accurately
detect disease and advance researchers' capabilities to develop the
next generation of diagnostics and therapeutics. BD has a presence
in virtually every country and partners with organizations around
the world to address some of the most challenging global health
issues. By working in close collaboration with customers, BD can
help enhance outcomes, lower costs, increase efficiencies, improve
safety and expand access to health care. For more information on
BD, please visit bd.com.
Contacts:
|
|
|
|
|
Troy
Kirkpatrick
|
|
|
Tony Di
Meo
|
BD Public Relations
|
|
|
BD
Investor Relations
|
858.617.2361
|
|
|
201.847.4166
|
troy.kirkpatrick@bd.com
|
|
|
Anthony_Di_Meo@bd.com
|
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SOURCE BD (Becton, Dickinson and Company)