FDA Medical Device Recalls (openFDA)
Baxa Corporation: Exacta Mix TPN (total parenteral nutrition) Bag, Model 740, 2000mL, Baxa Corporation
- Recall number
- Z-1032-2010
- Recalling firm
- Baxa Corporation
- Product
- Exacta Mix TPN (total parenteral nutrition) Bag, Model 740, 2000mL, Baxa Corporation
- Status
- Terminated
- Initiated
- 2009-11-12
- Posted
- 2010-03-09
- Terminated
- 2011-02-24
- 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
- 3110/50 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.
- Lot, serial or model codes
- Lot Numbers: 735020, 735134, 735135, 735136, 735137, 735138, 735139, 737607, 738007.
- 510(k) numbers
- ["K900585"]
- PMA numbers
- not on file
- Product code
- KPE
- Firm FEI
- 1419106
- Firm city
- Englewood
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28