Z-2470-2021Class II

Arjo Disposable Repositioning Sling, Model AHD001

Name: Z-2470-2021 Arjo Disposable Repositioning Sling, Model AHD001
Creator: Getinge Dominican Republic SA
Published: 2021-07-30
License: https://open.fda.gov/license/

Arjo Dominican Republic / initiated 2021-07-30 / Terminated / root cause: design

FDA source

Getinge Dominican Republic SA began a recall of Arjo Disposable Repositioning Sling, Model AHD001 on 2021-07-30. FDA classified it as Class II and gives the reason as "Sling loop straps on device pose a trip hazard". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2470-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-30
Posted: 2021-09-13
Terminated: 2023-08-11
Recalling firm: Arjo Dominican Republic
Product: Arjo Disposable Repositioning Sling, Model AHD001
Product code: FSA Lift, Patient, Non-Ac-Powered
Reason for recall: Sling loop straps on device pose a trip hazard.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2470-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2470-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-22	2021-09-13

Product code FSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)