Z-0906-06

Gri-bag: A single use, non pyrogenic flexible empty container with an incorporated 0.2 micron filter. It is...

Name: Z-0906-06 Gri-bag: A single use, non pyrogenic flexible empty container with an incorporated 0.2 micron filter. It is...
Creator: Instituto Grifols, S.A.
Published: 2005-11-29
License: https://open.fda.gov/license/

Laboratorios Grifols, S.A. / initiated 2005-11-29 / Terminated / root cause: labeling and UDI

FDA source

Instituto Grifols, S.A. began a recall of 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... on 2005-11-29. The reason FDA records is "When the bags are filled with solution, they leak. The labeling process caused a hole to be formed in the bag". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0906-06
Status: Terminated
Initiated: 2005-11-29
Posted: 2006-05-25
Terminated: 2006-12-05
Recalling firm: Laboratorios Grifols, S.A.
Product: 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.
Product code: KPE Container, I.V.
Reason for recall: When the bags are filled with solution, they leak. The labeling process caused a hole to be formed in the bag.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The consignees were notified by phone beginning November 11, 2005. They were requested to return the unused product in exchange for bags from other lot numbers. The returned product will be quarantined at the warehouse. All Gri-bags from batch X-003 will be destroyed.
Quantity in commerce: 218 units, each unit contains 5 bags.
Distribution: Distributed to health care facilities in California, Georgia and Oregon.
Product codes and lots: FPB NEP, batch # X-003, code 722842.

Product code KPE

K033916Class IIGri-Bag, Gri-Bag ApLaboratorios Grifols, S.A. / cleared 2003-12-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)