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Terminated

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,

FDA Recall Z-2152-2008 · Posted 2008-08-14

Recalling FirmOpti Medical Systems Inc
Recall StatusTerminated
Product CodeGIO
Date Initiated2008-05-08
Date Terminated2010-01-22
Product Quantity31750 tubes

Reason for Recall

This lot of Heparinized Capillary Tubes contain contaminated lithium heparin.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution: USA, Puerto Rico, Austria, China, Chile, Cyprus, Great Britain, Japan, Netherlands, and Senegal

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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