FDA Medical Device Recalls (openFDA)
Baxa Corporation: Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three brand names: Exacta Mix EVA Bags, Exacta Mix Dual-Chamber EVA Halobag, and Baxa Calibration Bags.
- Recall number
- Z-1420-2012
- Recalling firm
- Baxa Corporation
- Product
- Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three brand names: Exacta Mix EVA Bags, Exacta Mix Dual-Chamber EVA Halobag, and Baxa Calibration Bags.
- Status
- Terminated
- Initiated
- 2009-05-08
- Posted
- 2012-04-13
- Terminated
- 2012-04-13
- Reason
- Spike port flor EVA TPN Bags contains low levels of DEHP which could leach out.
- Root cause
- Labeling False and Misleading
- Action
- Baxa sent a Customer Notice letter dated May 8, 2009, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Current Baxa product is mislabeled as non-DEHP but this does not present a risk to patients. Baxa is committed to providing products that are non-DEHP. We are working with our supplier to replace the spike port with a non-DEHP as soon as possible. In the meantime, product labeling will be updated to reflect this finding. For further questions please call (303) 690-4204.
- Quantity
- 347,494 cases/ 50 bags each
- Distribution
- Worldwide Distribution -- USA (nationwide)
- Lot, serial or model codes
- Model 137, Size 250 ml, Cat. No. H938 137 3 Model 138, Size 500 ml, Cat No. H938 138 3 Model 139, Size 1000 ml, Cat No. H938 139 3 Model 140, Size 2000 ml,Cat. No. H938 140 3 Model 141, Size 3000 ml, Cat. No. H938 141 3 Model 142, Size 4000 ml, Cat. No. H938 142 3 Model 143, Size 5000 ml, Cat. No. H938 143 3 Model 341, Size 500/3000 ml, Cat No. H938 341 3
- 510(k) numbers
- ["K900585"]
- PMA numbers
- not on file
- Product code
- LHI
- 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