Facility
HUNTLEIGH HEALTHCARE LTD.
1 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 1000589001 |
|---|---|
| Establishment type | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility |
| Location | DIAGNOSTIC PRODUCT DIVISION CARDIFF, SOUTH GLAMORGAN, GB CF24 5HN |
| Registration status | Active · expires 2026 |
| Parent company | ARJOHUNTLEIGH AB (owner-operator 8010077) |
| Brand names | HYDROVEN FPR PUMP (SUZHOU - CONTRACT MFR), SPEC. DEVELOPER AND COMPLAINTS (HUNTLEIGH HEALTHCARE); HYDROVEN 3 PUMP (SUZHOU - CONTRACT MFR), SPEC. DEVELOPER AND COMPLAINTS (HUNTLEIGH HEALTHCARE); HYDROVEN GARMENTS (POZNAN - CONTRACT MFR), SPEC. DEVELOPER AND COMPLAINTS (HUNTLEIGH HEALTHCARE) |
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)
- ArjoHuntleigh Polska Sp. zo.o. (PL)
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-17. Verify this facility record at FDA →
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