Summary
The FDA issued a Class II for Arjo Disposable Repositioning Sling, Model AHD001 by Getinge Dominican Republic SA. Reason: Sling loop straps on device pose a trip hazard..
Details
Source
Device Recall
External ID
Z-2470-2021
Action Date
2021-09-22
Status
Terminated
Category
device
Product Description
Arjo Disposable Repositioning Sling, Model AHD001
Lot/Code Info: 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
Quantity Affected: 46,085 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-30
Company
Itabo, Haina, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Getinge Dominican Republic SA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Getinge Dominican Republic SA have FDA actions?
This is the only FDA action we have on record for Getinge Dominican Republic SA in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2470-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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