Facility
Arjo Dominican Republic
1 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3012292104 |
|---|---|
| Establishment type | Manufacture Medical Device |
| Location | Building 9 PIISA Industrial Park Itabo, Haina San Cristobal, DO 10903 |
| Registration status | Active · expires 2026 |
| Parent company | ArjoHuntleigh AB (owner-operator 10051620) |
| Brand names | Arjo Disposable Slide sheets; Arjo Disposable Slide Tube |
Devices registered here (1)
- Aid, TransferProduct code IKX · Class I · Physical Medicine · 21 CFR 890.5050
Recalls & enforcement
- Class IITerminated2013-09-11The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient
Related
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →
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