Z-0209-2009

Iris Sample Processing SafeCrit 40mm Tubes. Catalog number 59-000869-002 H. Iris Sample Processing, 60...

Name: Z-0209-2009 Iris Sample Processing SafeCrit 40mm Tubes. Catalog number 59-000869-002 H. Iris Sample Processing, 60...
Creator: Drummond Scientific Co
Published: 2008-08-01
License: https://open.fda.gov/license/

Drummond Scientific Co / initiated 2008-08-01 / Terminated / root cause: manufacturing process

FDA source

Drummond Scientific Co began a recall of Iris Sample Processing SafeCrit 40mm Tubes. Catalog number 59-000869-002 H. Iris Sample Processing, 60 Glacier Drive, Westwood, MA 02090. Heparin-treated... on 2008-08-01. The reason FDA records is "presence of OSCS contaminant". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0209-2009
Status: Terminated
Initiated: 2008-08-01
Posted: 2008-11-07
Terminated: 2008-12-18
Recalling firm: Drummond Scientific Co
Product: Iris Sample Processing SafeCrit 40mm Tubes. Catalog number 59-000869-002 H. Iris Sample Processing, 60 Glacier Drive, Westwood, MA 02090. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.
Product code: GIO Tube, Collection, Capillary Blood
Reason for recall: presence of OSCS contaminant
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: The recalling firm issued recall letters dated 8/1/08 via certified mail to the label owners informing them of the problem and the need to notified their customers.
Quantity in commerce: 4000 vials
Distribution: Nationwide Distribution --- including states of FL and MA.
Product codes and lots: Lot numbers 8121 exp 6/10, 8142 exp 7/10, & 8165 exp 8/10 and Catalog number 59-000857-002 G - Lot number 8200 exp 9/10

Product code GIO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)