Exacta Mix TPN (total parenteral nutrition) Bag, Model 738… recallZ-1030-2010 · Baxa Corporation · initiated Nov 12, 2009
Terminated All recalls posted in March 2010
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
TPN bags may leak fluid due to inadequate sealing.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1030-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 12, 2009
- Posted by the FDA
- Mar 9, 2010
- Recalling firm
- Baxa Corporation
- Quantity
- 646/50 bag cases
- Product code
- KPE
- FDA submissions
- K900585
- 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.
Product description
Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL, Baxa Corporation.
Code information (models, lots, serial numbers)
Lot numbers: 738391, 738392.
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
Other products in the same recall event
The FDA groups related products into one recall event (event 53893).
- Z-1031-2010 · TerminatedExacta Mix TPN (total parenteral nutrition) Bag, Model 739, 1000mL, Baxa Corporation
- Z-1032-2010 · TerminatedExacta Mix TPN (total parenteral nutrition) Bag, Model 740, 2000mL, Baxa Corporation
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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