Z-0164-2018Class II

Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box

Name: Z-0164-2018 Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box
Creator: Medline Industries Inc
Published: 2017-08-10
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2017-08-10 / Terminated / root cause: design

FDA source

Medline Industries Inc began a recall of Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box on 2017-08-10. FDA classified it as Class II and gives the reason as "The locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially allowing the belt strap to slip through the buckle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0164-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-10
Posted: 2017-11-21
Terminated: 2020-04-24
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.
Product code: IKX Aid, Transfer
Reason for recall: The locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially allowing the belt strap to slip through the buckle.
Root cause tag: design
FDA root cause: Device Design
Action: Medline Industries sent an Immediate Action Required Recall Notification letter via First Class mail dated August 10, 2017. The recall was later expanded and customers were notified via letter of the additional lots dated August 21, 2017. Instructions in both letters included to check inventory and quarantine any affected product, complete and return the included response form, coordinate the return of all affected product, and notify customers if the product was further distributed. Additional customers were identified and notified of the recall via the same process on September 19th, 2017. For further questions, please call (866) 359-1704.
Quantity in commerce: 1,428 units total
Distribution: USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NV, NY, OH , OK, OR, PA, RI, SC, TN, TX, VA, VT, WA, WI and WV.
Product codes and lots: Model No. MDT821203WPL, all lot numbers that begin with 90317XXXXXX. "X" represents any number.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0164-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0163-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-21
Z-0164-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-21

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)