Z-1321-06

Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer''s CLINITUBES kits...

Name: Z-1321-06 Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer''s CLINITUBES kits...
Creator: Radiometer America Inc
Published: 2006-03-22
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2006-03-22 / Terminated

FDA source

Radiometer America Inc began a recall of Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer''s CLINITUBES kits. The end caps are packaged in bags. These bags are... on 2006-03-22. The reason FDA records is "Capilliary end caps, an accessory for ABL blood gas analyzers, leak blood from capillary tubes during transport". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1321-06
Status: Terminated
Initiated: 2006-03-22
Posted: 2006-08-03
Terminated: 2012-02-24
Recalling firm: Radiometer America, Inc
Product: Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer''s CLINITUBES kits. The end caps are packaged in bags. These bags are placed in the capillary tube kit which also contains: capillary tubes, end caps, mixing wires, and a magnet. Each kit may contain 1 or 5 bags depending on the kit model. Each bag contains: 110 Green caps per bag and 160 Red caps per bag.
Product code: GIO Tube, Collection, Capillary Blood
Reason for recall: Capilliary end caps, an accessory for ABL blood gas analyzers, leak blood from capillary tubes during transport.
FDA root cause: Other
Action: The firm notified their customers of this recall action with a letter dated 3/22/2006. The letter was accompanied by a single bag of new end caps. The letter informs the customers of the ''leakage'' problem and asks that the customer examine their inventories and discard any of the referenced end caps found on-hand at any of their various locations. The letter also includes a response form to be faxed back to Radiometer indicating the amount of replacement capillary end caps required by the customer in addition to the one bag received. The recalling firm also notified the customers that the suspect end caps will all be replaced ASAP.
Quantity in commerce: Red Caps: 178 kits Each kit contains 1 to 5 bags of caps
Distribution: Nationwide, Canada and Istanbul.
Product codes and lots: Red Caps - Model #904-439 lot number less than 0535033

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)