ExactaMix EVA Container, Calibration Bag, REF: 735, Sterile… recallZ-1962-2011 · Baxa Corporation · initiated Mar 8, 2011
Terminated All recalls posted in April 2011
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 during filling operation, due to bag manufacturing error.
FDA root cause category: Nonconforming Material/Component
What the company is doing
The firm, BAXA, sent a "ExactaMix Bag Product Notice" dated March 8, 2011 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: If they do not intend to use the manual addition port, verify that the cap is firmly seated onto the port by gently tugging on the cap. If they do intend to use the manual addition port, they should snap off the additive port cap prior to compounding the bag. If they encounter a faulty additive port, contact Baxa Technical Support to receive credit and/or replacement on defective product only. To return affected bags, follow the instructions provided in the notice if the bags were purchased directly from Baxa or purchased from wholesaler, distributor or other 3rd party vendor. Additional copies of the return form can be retrieved by going to www.baxa.com/ebug OR by calling Baxa Technical Support at 800-678-2292. If you have any questions or concerns, contact the Sr. Vice President, Quality and Regulatory at (303) 400-2838 or Baxa Technical Support at 800-678-2292.
Recall details
- Recall number
- Z-1962-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 8, 2011
- Posted by the FDA
- Apr 12, 2011
- Recalling firm
- Baxa Corporation
- Quantity
- 50 bags
- Product code
- LHI
- FDA submissions
- K900585
- Distribution
- Worldwide distribution: USA (nationwide) and countries including: Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, Hong Kong, Ireland, Japan, Malaysia, Mexico, New Zealand, Panama, Puerto Rico, Singapore, South Korea, Taiwan, UK, Uruguay, Venezuela.
Product description
ExactaMix EVA Container, Calibration Bag, REF: 735, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set
Code information (models, lots, serial numbers)
All codes sold since 7/23/2009.
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 58304).
- Z-1963-2011 · TerminatedExactaMix EVA Container, 250mL, REF: 737, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to …
- Z-1964-2011 · TerminatedExactaMix EVA Container, 500mL, REF: 738, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to …
- Z-1965-2011 · TerminatedExactaMix EVA Container, 1000mL, REF: 739, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to…
- Z-1966-2011 · TerminatedExactaMix EVA Container, 2000mL, REF: 740, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to…
- Z-1967-2011 · TerminatedExactaMix EVA Container, 3000mL, REF: 741, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to…
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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