Safety Report: مضخة ضخ Alaris - تم استدعاؤها بسبب مشكلات الأجهزة قد تتسبب في عدم تشغيل مضخة التسريب كما هو متوقع, USA

United States

Company name: Becton, Dickinson and Company
Brand name: Alaris
Product recalled: Alaris Infusion Pump
Reason of the recall: Hardware issues may cause the infusion pump to not operate as expected
FDA Recall date: September 01, 2020
Recall details: 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

Check the list of affected Products on the link below. 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.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-provides-update-previously-disclosed-recall-bd-alaris-system-hardware

Source: FDA