Facility
ArjoHuntleigh Polska Sp. zo.o.
1 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3007420694 |
|---|---|
| Establishment type | Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device |
| Location | Ul. Ks. Wawrzyniaka 2 Poznan Wielkopolskie, PL 62052 |
| Registration status | Active · expires 2026 |
| Parent company | ARJOHUNTLEIGH AB (owner-operator 8010077) |
| Brand names | FLOWTRON DVT5 GARMENT (POZNAN - MFR & COMPLAINTS) |
Devices registered here (1)
- Sleeve, Limb, CompressibleProduct code JOW · Class II · Cardiovascular · 21 CFR 870.5800
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
- All facilities operated by ARJOHUNTLEIGH AB
- Arjo (Suzhou) Co., Ltd. (CN)
- HUNTLEIGH HEALTHCARE LTD. (GB)
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-17. Verify this facility record at FDA →
Watch ArjoHuntleigh Polska Sp. zo.o.
We'll email you when a new FDA recall or enforcement record is published for a facility you follow. (Inspection & warning-letter coverage is being added.)
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.