Highest risk U.S. Food and Drug Administration

Alaris Infusion Pump recall: Hardware issues may cause the infusion pump to not operate as expected

Recall published 6+ years ago

Hardware issues may cause the infusion pump to not operate as expected

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Published
August 20, 2020
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Alaris
Product type
Medical devices

Products covered by this recall

Alaris Infusion Pump

What the company announced

Majority of June 30 Recall Designated as Class I Recall by FDA

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: Alaris™ System PC Unit Model 8000 · Situation 1: X · Situation 3*: X
  • Product Name: Alaris™ System PC Unit Model 8015 · Situation 1: X · Situation 3*: X · Situation 4: X
  • Product Name: Alaris™ Pump Module Model 8100 · Situation 1: X · Situation 2: X · Situation 4: X
  • Product Name: Alaris™ Syringe Module Model 8110 · Situation 1: X · Situation 4: X
  • Product Name: Alaris™ PCA Module Model 8120 · Situation 1: X · Situation 4: X
  • Product Name: Alaris™ EtCO2 Module Model 8300 · Situation 1: X · Situation 4: X
  • Product Name: Alaris™ SpO2 Module Model 8210 and Model 8220 · Situation 1: X · Situation 4: X
  • Product Name: Alaris™ Auto ID Module Model 8600 · Situation 1: 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 [email protected] .

FDA MedWatch Reporting

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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

BD Public Relations

858.617.2361

[email protected]

Tony Di Meo

BD Investor Relations

201.847.4166

[email protected]

SOURCE BD (Becton, Dickinson and Company)

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 9 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Model or item number

On the rating label, the box or the instruction sheet.

  • 8000
  • 8015
  • 8100
  • 8110
  • 8120
  • 8300
  • 8210
  • 8220
  • 8600

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Alaris — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Becton, Dickinson and Company — Consumers: BD's Recall Support Center, 888-562-6018, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Alaris medical devices recalled?

Hardware issues may cause the infusion pump to not operate as expected 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: model number 8000, 8015, 8100. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

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