Recalls / —
—#159346
Product
Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.
- FDA product code
- IKX — Aid, Transfer
- Device class
- Class 1
- Medical specialty
- Physical Medicine
- Affected lot / code info
- Model No. MDT821203WPL, all lot numbers that begin with 90317XXXXXX. "X" represents any number.
Why it was recalled
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 (FDA determination)
Device Design
Action the firm took
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.
Recalling firm
- Firm
- Medline Industries Inc
- Address
- Three Lakes Drive, Northfield, Illinois 60093
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2017-08-10
- Terminated
- 2020-04-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #159346. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.