Recall Z-0055-2021

Reason for recall

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

FDA-determined cause: Process design

Action taken

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 recalls@medline.com 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.