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FDA Medical Device Recalls (openFDA)

Medline Industries Inc: Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.

Recall number
Z-0163-2018
Recalling firm
Medline Industries Inc
Product
Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.
Status
Terminated
Initiated
2017-08-10
Posted
not on file
Terminated
2020-04-24
Reason
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
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
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.
Lot, serial or model codes
Model No. MDT821203WP, all lot numbers that begin with 90317XXXXXX. "X" represents any number.
510(k) numbers
not on file
PMA numbers
not on file
Product code
IKX
Firm FEI
1417592
Firm city
Northfield
Firm state
IL
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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