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U.S. Department of Health and Human Services

Class 2 Device Recall Arjo Disposable Repositioning Sling

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  Class 2 Device Recall Arjo Disposable Repositioning Sling see related information
Date Initiated by Firm July 30, 2021
Create Date September 13, 2021
Recall Status1 Terminated 3 on August 11, 2023
Recall Number Z-2470-2021
Recall Event ID 88403
Product Classification Lift, patient, non-ac-powered - Product Code FSA
Product Arjo Disposable Repositioning Sling, Model AHD001
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
Recalling Firm/
Manufacturer		 Getinge Dominican Republic SA
Building 9 Piisa Industrial Park
Km. 18 1/2 Antigua Carretera Sanchez
Itabo, Haina Dominican Republic (the)
For Additional Information Contact Esteban Encarnacion
630-945-7375
Manufacturer Reason
for Recall		 Sling loop straps on device pose a trip hazard.
FDA Determined
Cause 2		 Device Design
Action The Field Safety Notification (FSN) will be accompanied by a Customer Response Form. The customer will be asked to acknowledge the FSN reception, complete and sign an enclosed Customer Response Form and return it to the local Arjo office (address indicated in the FSN) in order to confirm that the caution and additionally provided instructions are understood and followed by personnel.
Quantity in Commerce 46,085 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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