Baxa EVA TPN bags for administering parenteral nutrition… recallZ-1420-2012 · Baxa Corporation · initiated May 8, 2009
Terminated All recalls posted in April 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxa Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Spike port flor EVA TPN Bags contains low levels of DEHP which could leach out.
FDA root cause category: Labeling False and Misleading
What the company is doing
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.
Recall details
- Recall number
- Z-1420-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 8, 2009
- Posted by the FDA
- Apr 13, 2012
- Recalling firm
- Baxa Corporation
- Quantity
- 347,494 cases/ 50 bags each
- Product code
- LHI
- FDA submissions
- K900585
- Distribution
- Worldwide Distribution -- USA (nationwide)
Product description
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.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
8 devices cleared under K900585 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- EXACTAMIX H938740Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,350 reports
- EXACTAMIX H938738Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,180 reports
- EXACTAMIX H938739Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall972 reports
- EXACTAMIX H938741Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall710 reports
- EXACTAMIX H938737Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall607 reports
- EXACTAMIX H938742Baxter Healthcare Corporation · Set, i.V. Fluid transfer93 reports
- EXACTAMIX H938743Baxter Healthcare Corporation · Set, i.V. Fluid transfer87 reports
- EXACTAMIX H938735Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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