FRANKLIN LAKES, N.J.,
July 18, 2019 /PRNewswire/ -- BD
(Becton, Dickinson and Company) (NYSE: BDX), a leading global
medical technology company, today provided an update on two
voluntary recalls related to certain Alaris™ Pump Modules Model
8100 manufactured between April 2011
and June 2017 and certain model codes
and lot numbers of the Alaris™ Pump Infusion Sets used with the
Alaris™ Pump Model 8100. BD has already notified customers affected
by these recalls. Both products were formerly marketed under the
CareFusion brand, which BD acquired in March
2015.
Both actions have been designated as a Class I recall by the
U.S. Food and Drug Administration (FDA). Both recalls have been
associated with medical device reporting (MDR) submissions, several
of which are associated with serious injuries.
Alaris™ Pump Module Model 8100
In a recall notification sent on April
15, 2019, BD informed clinicians that the bezel assemblies
in the Alaris pump modules subject to this recall expansion were
manufactured with a specific type of plastic material. The company
conducted an investigation and determined that the bezel
manufacturing process resulted in weakened plastic. Over time,
further weakening of the plastic has the potential to lead to
separation of the bezel posts, as well as other damage to the
bezel, which may result in free-flow, over-infusion, under-infusion
or interruption of infusion.
No products manufactured after June
2017 are affected by this recall, including the BD Alaris™
PCU and BD Alaris™ Pump Module that were introduced in March 2018.
BD is contacting the customers affected by the Alaris Pump
Module Model 8100 bezel recall to schedule replacement of bezel
assemblies. On April 15, 2019, the BD
customer notification instructed customers to inspect all pumps
included in this action during the annual preventive maintenance,
and if damage is found, the pump should be removed from service and
BD should be contacted. The revised recall notification
indicates that until the bezels affected by this recall are
replaced, customers should inspect both Priority 1 and Priority 2
pumps as soon as feasible. In addition to posting the
updated recall notification on BD's website, this updated
notification will be sent to all customers by July 31, 2019.
There are no changes to the affected product list. Customers
should continue to refer to the attachments included in the recall
notification issued on April 15,
2019.
Information about this recall, including the original and
updated recall notification, is available on BD's website at
alaris.bdproductnotice.com or call BD at 888-562-6018.
Alaris™ Infusion Sets
In a recall notification sent on May 6,
2019, BD confirmed that an incomplete occlusion can occur on
the pumping segment of certain Alaris™ Pump Model 8100 infusion
sets. This is caused by a variation in the wall thickness of the
pumping segment of the affected infusion sets. Use of the affected
products has the potential to lead to unintended delivery of
medication when the pump module is not in running status, flow
inaccuracies through the pumping cycle process resulting in an
over-infusion, and the potential for serious patient injury
depending on the type of medication that is being delivered.
Instructions for customers, including a full list of affected
product codes, lot numbers and expiration dates are included on the
BD website
at https://www.bd.com/en-us/support/recall-notifications/recall-notification-alaris-pump-infusion-sets.
BD is instructing customers to destroy all Alaris Infusion Sets
affected by this recall.
Customer inquiries related to this action should be addressed to
BD's Regional Customer Quality team at 888-237-2762.
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:
Kristen
Cardillo
|
Monique N.
Dolecki
|
BD Public
Relations
|
BD Investor
Relations
|
201.847.5657
|
201.847.5378
|
kristen.cardillo@bd.com
|
Monique_Dolecki@bd.com
|
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SOURCE BD (Becton, Dickinson and Company)