Exacta-Mix Valve Set, Primary Valve with Detachable Pump… recallZ-0978-04 · Baxa Corporation · initiated Apr 30, 2004
Terminated All recalls posted in July 2004
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
A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.
FDA root cause category: Other
What the company is doing
Consignees were notified by phone, fax and letter beginning 4/30/2004.
Recall details
- Recall number
- Z-0978-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 30, 2004
- Posted by the FDA
- Jul 20, 2004
- Recalling firm
- Baxa Corporation
- Quantity
- 50 cases (10 per case)
- Product code
- LHI
- FDA submissions
- K900585
- Distribution
- Nationwide, including 6 military hospitals and two VA facilities. Foreign distribution to Argentina, Brazil, Canada, Columbia, Hong Kong, Korea, Malaysia, Mexico, Panama, Singapore, Taiwan, UK, and Venezuela.
Product description
Exacta-Mix Valve Set, Primary Valve with Detachable Pump Tube
Code information (models, lots, serial numbers)
Order No. REF: 69
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 29037).
- Z-0979-04 · TerminatedExacta-Mix Valve Set, Secondary Valve Assembly
- Z-0980-04 · TerminatedExacta-Mix Valve Set, Six Inlet, Non-Vented, Assembled
- Z-0981-04 · TerminatedExacta-Mix Valve Set, Six Inlet, Tubing Kit
- Z-0982-04 · TerminatedExacta-Mix Valve Set, Primary Valve Assembly
- Z-0983-04 · TerminatedExacta-Mix Valve Set, Primary Valve Assembly, Pediatric
- Z-0984-04 · TerminatedExacta-Mix Valve Set, Primary Valve Assembly
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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