BD Alaris Infusion Pump System Recall [US]


BD Alaris Infusion Pump System Recall [US]

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US FlagUS/Silver Spring: Becton, Dickinson and Company (“BDC”), a Franklin Lakes, New Jersey establishment, updates its existing recall for various models of BD Alaris Infusion Pump Systems from the American marketplace after an upgrading and reclassification of the original notification published by the US Food and Drug Administration (“FDA”) to Class I, the most serious and potentially deadly classification of medical device recall.

The original recall was initiated due to possible operational failure and consequential inaccurate dosage, failure to dose and possible life-changing complications including death, all serious health and safety hazards.

FDA: http://ht.ly/Irmt30r8C9r

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-provides-update-previously-disclosed-recall-bd-alaris-system-hardware

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Infusion Pump Systems are subject to this recall:

BD Alaris Infusion Pump Systems, various models as follows:

  • Alaris Auto ID Module, Model 8600
  • Alaris EtCO2 Module, Model 8300
  • Alaris PCA Module, Model 8120
  • Alaris Pump Module, Model 8100
  • Alaris SpO2 Module, Model 8210 and Model 8220
  • Alaris Syringe Module, Model 8110
  • Alaris System PC Unit, Model 8000
  • Alaris System PC Unit, Model 8015

Please consult the photograph above for details of the medical device’s design and retail presentation.

==> No barcodes, NDC, DINs, item numbers, best-before date codes, manufacturing date codes, production dates, expiry dates, regulatory approval designations, registration numbers, agency approval designations or other identification numbers were listed with this recall notification.

According to the FDA, Becton, Dickinson and Company has initiated the voluntary recall to notify customers of the potential for four (4) hardware situations that may result in the Infusion Pump not operating as expected. BDC has provided instructions to correct and/or mitigate the situations. The four situations include:

  1. Damaged Inter-Unit Interface (IUI) Connectors (Situation 1 – Class I)
  2. Broken elements on Alaris™ Pump Module platen (Situation 2 – Class I)
  3. Improperly secured PC unit Battery (Situation 3 – Class I)
  4. Dim LED Segment(s) on the Alaris™ modules (Situation 4 – Class II)

Customers and users of these Pumps should review the following letter:
http://www.bd.com/en-us/support/recall-notifications/recall-notification-for-alaris-system-infusion-pump-hardware

==> If you have a medical emergency, please contact 9-1-1, your closest hospital or emergency center equipped to properly treat non-functional medical equipment.

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US Centers for Disease Control and Prevention Coronavirus Tips___________________________________________________________

If you have any further questions, comments or complaints about this recall, please contact BD’s Recall Support Center toll-free at 1-888-562-6018 during normal business hours Eastern Standard Time, Monday to Friday or by e-mail at or SupportCenter@bd.com.

==> To see other recalls and notifications caused by suspected faulty and/or dangerous medical equipment, please search for “medical” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Becton, Dickinson, please search for “Becton” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 13481-2020
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
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Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe food or drug you purchased in the US [external: new window opens]:
==> http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

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