FDA Medical Device Recalls (openFDA)
Getinge Dominican Republic SA: Arjo Disposable Repositioning Sling, Model AHD001
- Recall number
- Z-2470-2021
- Recalling firm
- Getinge Dominican Republic SA
- Product
- Arjo Disposable Repositioning Sling, Model AHD001
- Status
- Terminated
- Initiated
- 2021-07-30
- Posted
- not on file
- Terminated
- 2023-08-11
- Reason
- Sling loop straps on device pose a trip hazard.
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSA
- Firm FEI
- 3012292104
- Firm city
- Haina
- Firm state
- not on file
- Firm country
- Dominican Republic the
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28