HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's f

FDA device recall Z-1329-2024 · posted 2024-03-20 · Open, Classified

Recall details

Recalling firm

Baxter Healthcare Corporation

Reason for recall

Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction System, Traction Boot II, due to the boots being assembled incorrectly. The locking ridge on the front face of the boot key socket is facing upwards, which prevents the socket mechanism on the traction boot from attaching properly to the spar of the traction system. This will cause the boot to detach from the traction system.

Action taken

Baxter issued an Urgent Medical Device Recall notice to its sole consignee on 03/11/2024 via email. The notice explained the issue and potential hazard and requested the following: 1. Immediately locate, isolate, and cease all use of the affected serial numbers of the product. The product code and serial number can be found on labelling on the bottom of the boot. 2. Arrange for the return of your impacted product by calling the Baxter Order Management Team at 800-433-5774, option 2 then 3, between the hours of 8:00 am and 5:00 pm Eastern Time, Monday through Friday, or by emailing Baxter at hrc_amatech_orders@baxter.com. 3. Acknowledge the receipt of this notification by completing a reply form on the customer portal.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

HST

Quantity affected

80 units

Distribution

US Nationwide distribution in the state of Florida.

Date initiated

2024-03-11

Date posted

2024-03-20

Location

Deerfield, IL