Z-2152-2008

Vitrex Blood Gas Capillary Tubes, MC0024, REF 189301, 250 pcs, 1,45 x 1,85 x 125 mm app. 200l, Heparinized: 6...

Name: Z-2152-2008 Vitrex Blood Gas Capillary Tubes, MC0024, REF 189301, 250 pcs, 1,45 x 1,85 x 125 mm app. 200l, Heparinized: 6...
Creator: Opti Medical Systems Inc
Published: 2008-05-08
License: https://open.fda.gov/license/

Opti Medical Systems Inc / initiated 2008-05-08 / Terminated / root cause: manufacturing process

FDA source

Opti Medical Systems Inc began a recall of Vitrex Blood Gas Capillary Tubes, MC0024, REF 189301, 250 pcs, 1,45 x 1,85 x 125 mm app. 200l, Heparinized: 6 IU Na & 9 IU Li/100 l on 2008-05-08. The reason FDA records is "This lot of Heparinized Capillary Tubes contain contaminated lithium heparin". 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-2152-2008
Status: Terminated
Initiated: 2008-05-08
Posted: 2008-08-14
Terminated: 2010-01-22
Recalling firm: Opti Medical Systems Inc
Product: Vitrex Blood Gas Capillary Tubes, MC0024, REF 189301, 250 pcs, 1,45 x 1,85 x 125 mm app. 200l, Heparinized: 6 IU Na & 9 IU Li/100 l,
Product code: GIO Tube, Collection, Capillary Blood
Reason for recall: This lot of Heparinized Capillary Tubes contain contaminated lithium heparin.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Opti Medical sent a Recall Notice, dated May 8, 2008 to all consignees. Consignees were notified via email on/about May 5th thru 7th , 2008. They were instructed to discontinue use of the affected lot and to immediately return all remaining product to OPTI Medical for replacement.
Quantity in commerce: 31750 tubes
Distribution: Worldwide Distribution: USA, Puerto Rico, Austria, China, Chile, Cyprus, Great Britain, Japan, Netherlands, and Senegal
Product codes and lots: Part #MC0024, Lot #1112254

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)