Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL, Baxa Corporation.
FDA device recall Z-1030-2010 · posted 2010-03-09 · Terminated
Recall details
- Recalling firm
- Baxa Corporation
- Reason for recall
- TPN bags may leak fluid due to inadequate sealing.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KPE
- Quantity affected
- 646/50 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, Tai
- Date initiated
- 2009-11-12
- Date posted
- 2010-03-09
- Date terminated
- 2011-02-24
- Location
- Englewood, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP (K900585) | Baxa Corp., Sub. of Cook Group, Inc. | 1990-04-18 |