Recall Z-1080-2011 ยท LRS I.V. Start Kit
Centurion Medical Products
Centurion Medical Products Insertion/PPE Kit CV12590, Sterile.
| Date | Feb 9, 2011 (initiated Jun 2, 2010) |
| Status | Terminated |
| Reason | The kits contain heparin lock flush solution USP code 504505 that is under recall by APP Pharmaceuticals. APP Pharmaceuticals is recalling the heparin because of incomplete documentation associated with test results. |
| Root cause | Nonconforming Material/Component |
| Action | Centurion Medical Products sent out Urgent Product Recall Notices on 6/3/2010. A second recall notice was sent to nonresponding consignees on 6/21/2010. The letter instructed the consignees to quarantine the recalled product and contact Centurion so that the recalled product can be retrieved. |
| Quantity | 20 |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.