BD today provided an update on a previously announced voluntary recall of the BD Alaris™ System.
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