Health product recall

BD Alaris Large Volume Pump

Last updated

Summary

Product
BD Alaris Large Volume Pump
Issue
Medical devices - Device compatibility
What to do

Review/perform action in recall notice, post recall notice on/near device, complete/return reply form. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

BD Alaris Large Volume Pump

All lots.

8100

Issue

BD is recalling the product because if a third-party screw is used, or potentially if the BD manufactured pivot latch screw is reused or improperly installed, it may back out, interfering with door closure, which can lead to over or under infusion. The current BD pivot latch screw design, which was introduced in 2009, includes retaining microspheres that prevent the screw from backing out when properly installed in accordance with labeling. We are notifying customers to ensure that (1) all pivot latch screws are inspected by hospital staff prior to use of lvp, (2) all loose, backed out, and third-party screws are replaced by the hospital biomed staff with new BD manufactured pivot latch screws in accordance with the labeling, and (3) customers are aware of the risks associated with backed-out pivot latch screws.

Recall start date: November 15, 2022

Additional information

Details
Original published date: 2022-12-01
Alert / recall type
Health product recall
Category
Health product - Medical device - General hospital and personal use
Companies

Carefusion 303, Inc.

10020 Pacific Mesa Blvd., San Diego, California, United States, 92121-2733

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72229