Z-0055-2021Class II

Quick Release Gait Belt, 60

Name: Z-0055-2021 Quick Release Gait Belt, 60
Creator: Medline Industries Inc
Published: 2020-09-15
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2020-09-15 / Open, Classified / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of Quick Release Gait Belt, 60 on 2020-09-15. FDA classified it as Class II and gives the reason as "The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0055-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-09-15
Posted: 2020-10-05
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Quick Release Gait Belt, 60
Product code: IKX Aid, Transfer
Reason for recall: The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.
Root cause tag: manufacturing process
FDA root cause: Process design
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.
Quantity in commerce: 13,500 units
Distribution: Domestic Distribution Only: IL, MI
Product codes and lots: Model: MDT821208NATM /503689 Lots: 33019040001, 33019090001 and 33019100001 Used in kits with model number: DYKF1045 Lots: 20EBB832 and 20EBM643.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0055-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0055-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-14	2020-10-05

Product code IKX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)