Laboratorios Grifols, S.A.
PARETS DEL VALLES Barcelona, ES
LABORATORIOS GRIFOLS, S.A. appears in FDA device records in PARETS DEL VALLES Barcelona, ES. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Laboratorios Grifols, S.A. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Instituto Grifols, S.A.recall
510(k) clearance history
FDA records hold 9 510(k) clearances for Laboratorios Grifols, S.A. between 2003 and 2017. The busiest year on record is 2003, with 3. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 3 |
| 2004 | 1 |
| 2005 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K162216 | GRI-FILL PERISTALTIC SET | LHI | Substantially Equivalent | |
| K102590 | FLEBOSET DOUBLE | LHI | Substantially Equivalent | |
| K093182 | SET GRI-FILL 3.0 | LHI | Substantially Equivalent | |
| K082752 | QUICKPIN | LHI | Substantially Equivalent | |
| K050339 | SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE | LHI | Substantially Equivalent | |
| K040456 | FLEBOSET MULTIPLE | LHI | Substantially Equivalent | |
| K033916 | GRI-BAG, GRI-BAG AP | KPE | Substantially Equivalent | |
| K033682 | SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE | LHI | Substantially Equivalent | |
| K031419 | GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML | KPE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002807257 | 3002807257 | LABORATORIOS GRIFOLS, S.A. | POL. LEVANTE C/CAN GUASCH, 2, PARETS DEL VALLES Barcelona 08150 ES | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0906-06 | Gri-bag: A single use, non pyrogenic flexible empty container with an incorporated 0.2 micron filter. It is supplied sterile in sealed peel-pack pouches. It is used to remove particulates in the Gri-fill pharmacy compounding system and as a container in the preparation of drug solutions. Gri-bag 500 ml. | When the bags are filled with solution, they leak. The labeling process caused a hole to be formed in the bag. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain