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
FDA device recall Z-2152-2008 · posted 2008-08-14 · Terminated
Recall details
- Recalling firm
- Opti Medical Systems Inc
- Reason for recall
- This lot of Heparinized Capillary Tubes contain contaminated lithium heparin.
- Action taken
- 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
- Status
- Terminated
- Product code
- GIO
- Quantity affected
- 31750 tubes
- Distribution
- Worldwide Distribution: USA, Puerto Rico, Austria, China, Chile, Cyprus, Great Britain, Japan, Netherlands, and Senegal
- Date initiated
- 2008-05-08
- Date posted
- 2008-08-14
- Date terminated
- 2010-01-22
- Location
- Roswell, GA
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