FDA Recall Open, Classified

Quick Release Gait Belt, 60

Recall: Z-0055-2021 · Initiated September 15, 2020

Recall

Recall Number
Z-0055-2021
Event Number
86448
Firm
Medline Industries Inc
FEI Number
1417592
Product Code
IKX
Status
Open, Classified
Root Cause
Process design
Initiated
September 15, 2020
Address
3 Lakes Dr, Northfield, IL, 60093-2753

Description

Quick Release Gait Belt, 60

Reason

The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.

Action

On Sep 15 2020 the firm sent an notification to its customers via email, with the following instructions: REQUIRED ACTION: 1. Immediately check your stock for the specific kit number and the affected kit lot number in the attached list. Quarantine any kits with the listed lot numbers. If you dont have any of the lots listed above skip to step 3. 2. Remove affected Gait Belts prior to use of the Fall Prevention Kit. Please be sure NOT to use the recalled Gait Belts and return those to Medline. Medline will supply replacement belts at no charge to you. 3. Please return the completed enclosed verification form listing the quantity of affected product on hand. Even if you do not have any affected product please complete and return the form, via email as indicated on the verification form. 4. Return the enclosed Verification Form via email to [email protected] or fax 866-767-1290. 5. If you are a distributor, promptly notify any of your customers that may have received affected product. Note: By signing and returning the Verification Form, you acknowledge that you received and understand this notification.

Distribution

Domestic Distribution Only: IL, MI

Quantity

13,500 units