FDA Medical Device Recalls (openFDA)
Baxa Corporation: Exacta-Mix EVA Container, Sterile R, 2000 mL, Order No. REF: 140, Baxa Corporation.
- Recall number
- Z-2140-2010
- Recalling firm
- Baxa Corporation
- Product
- Exacta-Mix EVA Container, Sterile R, 2000 mL, Order No. REF: 140, Baxa Corporation.
- Status
- Terminated
- Initiated
- 2010-05-26
- Posted
- 2010-08-02
- Terminated
- 2011-08-04
- Reason
- Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
- Root cause
- Process design
- Action
- 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.
- Quantity
- 3,306,700 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, and Uruguay.
- Lot, serial or model codes
- All lot numbers
- 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
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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