Exacta-Mix EVA Container, Sterile R, 4000 mL, Order No. REF: 142, Baxa Corporation.
FDA device recall Z-2142-2010 · posted 2010-08-02 · Terminated
Recall details
- Recalling firm
- Baxa Corporation
- Reason for recall
- Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
- Action taken
- Consignees were notified by e-mail and Baxa Bag Product Notice letter on 05/26/2010 with instructions to not use any bags if the fill port cap is detached. Photos of a detached cap and properly attached cap were included. Defective bags could be returned to Baxa for credit. Information available at 800-678-2292.
- Root cause
- Process design
- Status
- Terminated
- Product code
- KPE
- Quantity affected
- 263,150 bags
- Distribution
- Worldwide distribution, including USA, Argentina, Australia, Bermuda, Brazil, Canada, China, Colombia, Hong Kong, Malaysia, Mexico, New Zealand, Pakistan, Panama, South Korea, Taiwan, United Kingdom,
- Date initiated
- 2010-05-26
- Date posted
- 2010-08-02
- Date terminated
- 2011-08-04
- 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 |