Recall Z-2152-2008 ยท GIO Tube, Collection, Capillary Blood
Opti Medical Systems Inc
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,
| Date | Aug 14, 2008 (initiated May 8, 2008) |
| Status | Terminated |
| Reason | This lot of Heparinized Capillary Tubes contain contaminated lithium heparin. |
| 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 | 31750 tubes |
| Distribution | Worldwide Distribution: USA, Puerto Rico, Austria, China, Chile, Cyprus, Great Britain, Japan, Netherlands, and Senegal |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.