Z-0975-2007

SafeClinitubes, REF 942-892, D957P-70-100x1, contained in kits containing 250 SafeClinitubes, insert, mixing...

Name: Z-0975-2007 SafeClinitubes, REF 942-892, D957P-70-100x1, contained in kits containing 250 SafeClinitubes, insert, mixing...
Creator: Radiometer America Inc
Published: 2006-06-22
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2006-06-22 / Terminated / root cause: manufacturing process

FDA source

Radiometer America Inc began a recall of SafeClinitubes, REF 942-892, D957P-70-100x1, contained in kits containing 250 SafeClinitubes, insert, mixing wires and end caps. Capillary samplers for drawing... on 2006-06-22. The reason FDA records is "The clinitubes are not able to be filled due to contamination with silicone during production". 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-0975-2007
Status: Terminated
Initiated: 2006-06-22
Posted: 2007-07-03
Terminated: 2012-05-08
Recalling firm: Radiometer America, Inc
Product: SafeClinitubes, REF 942-892, D957P-70-100x1, contained in kits containing 250 SafeClinitubes, insert, mixing wires and end caps. Capillary samplers for drawing small amounts of blood for blood gas analysis.
Product code: GIO Tube, Collection, Capillary Blood
Reason for recall: The clinitubes are not able to be filled due to contamination with silicone during production.
Root cause tag: manufacturing process
FDA root cause: Other
Action: The firm notified their customers of this recall with a letter dated 6/22/2006. The letter informs the customers of the problem with the affected lots of SafeCLINITUBES and asks that the customers discard any remaining boxes of affected product on-site. The recall letter is accompanied by a FAX FORM (response form) which the customer is asked to complete in order to request replacement product to be sent to their individual locations.
Quantity in commerce: 175 boxes
Distribution: Nationwide and Canada.
Product codes and lots: Lot R0043, exp. 01/2008; R0044, exp. 01/2008; and R0045, exp. 03/2008.

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)