Recall Z-1031-2010 ยท KPE Container, I.V.
Baxa Corporation
Exacta Mix TPN (total parenteral nutrition) Bag, Model 739, 1000mL, Baxa Corporation
| Date | Mar 9, 2010 (initiated Nov 12, 2009) |
| Status | Terminated |
| Reason | TPN bags may leak fluid due to inadequate sealing. |
| Root cause | Process control |
| Action | Consignees were notified by Baxa Urgent Exactamix Bag Recall letter on 11/12/2009 and then again on 11/17/2009 when more lots were found to be affected. Instructions were to stop use and return all affected product to Baxa. More information is available at 800-678-2292. |
| Quantity | 2110/50 bag cases |
| Distribution | Worldwide distribution, including USA, Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, Hong Kong, Japan, Malaysia, Mexico, New Zealand, Panama, Peru, Singapore, South Korea, Taiwan, and Uruguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K900585 | TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP Baxa Corp., Sub. of Cook Group, Inc., Apr 18, 1990 |