FDA recall Z-2470-2021

Getinge Dominican Republic SA · Class II · device

Product

Arjo Disposable Repositioning Sling, Model AHD001

Reason for recall

Sling loop straps on device pose a trip hazard.

Distribution

US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MD, ME, MI, MN, MO, MS, NC, ND, NJ, NM, NY, OH, OR, PA, SC, TN, TX, VA, VT, WI, and WV.

Key facts

Status
Terminated
Initiation date
2021-07-30
Report date
2021-09-22
Termination date
2023-08-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Itabo, Haina, N/A, Dominican Republic (the)

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2470-2021