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Recall Observatory FDA recall evidence

Device product

Arjo Disposable Repositioning Sling, Model AHD001

Z-2470-2021

July 30, 2021

Class II

Product summary

Firm
Getinge Dominican Republic SA
Event
Event 88403
Status
Terminated
Classification
Class II
Quantity
46,085 units
Official record key
device-enforcement:Z-2470-2021

Official wording

Reason: Sling loop straps on device pose a trip hazard.

Code information: Model Number AHD001; Lots DAG1300482, DAG1300483, DAG1300484, DAG1300485, DAG1300486, DAG1300487, DBG1300488, DBG1300489, DBG1300490, DBG1300491, DBG1300492, DBG1300493, DBG1300494, DBG1300495, DBG1300496, DBG1300497, DBG1300498, DBG1300499, DCG1300500,, DCG1300501, DCG1300502, DCG1300503, DCG1300504, DCG1300505, DCG1300506, DCG1300507, DCG1300508, DCG1300509, DCG1300510, DCG1300511, DCG1300513 DCG1300514, DCG1300515, DDG1300516, DDG1300517, DDG1300518, DDG1300519, DDG1300520, DDG1300521, DAG1300522, DDG1300523, DDG1300524, DDG1300525, DDG1300526, DEG1300527, DEG1300528, DEG1300529, DEG1300530, DEG1300531, DEG1300532, DEG1300533, DEG1300534, DEG1300535, DEG1300536, DFG1300537

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sling loop straps on device pose a trip hazard.