Recall Z-2152-2008
Opti Medical Systems Inc · initiated May 8, 2008
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,
Codes / lots: Part #MC0024, Lot #1112254
Reason for recall
This lot of Heparinized Capillary Tubes contain contaminated lithium heparin.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-2152-2008
- Initiated
- May 8, 2008
- Posted by FDA
- August 14, 2008
- Terminated
- January 22, 2010
- Product code
- GIO – Tube, Collection, Capillary Blood
- Quantity
- 31750 tubes
- Distribution
- Worldwide Distribution: USA, Puerto Rico, Austria, China, Chile, Cyprus, Great Britain, Japan, Netherlands, and Senegal
- Recalling firm
- Opti Medical Systems Inc, Roswell, GA