0.2 Micron Filter, 50 mm recallZ-0007-2017 · Baxter Corporation Englewood · initiated Aug 24, 2016
Class I Terminated All recalls posted in October 2016
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 Baxter Corporation Englewood 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
Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2 Micron Filter (Product Code: H93835) due to the potential for the filter membrane layer to be missing and for particulate matter to be present.
FDA root cause category: Nonconforming Material/Component
What the company is doing
The firm, Baxter, sent an "URGENT PRODUCT RECALL" letter dated 8/24/2016 to its Consignees/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) locate and remove all affected product; 2) contact Baxter Health Care Center for Service to arrange for return of product at 888-229-0001 between the hours of 7am-6pm Central Time, Monday-Friday; 3) Complete and return the Customer Reply form to Baxter via fax to 224-270-5457 or scan and email to [email protected], and 4) if you distributed this product to others facilities or department within your institutions forward copy of the communication. For general questions, contact Baxter Product Surveillance at 800-437-5176 between the hours of 8am-5pm Central Time, Monday through Friday.
Recall details
- Recall number
- Z-0007-2017
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Aug 24, 2016
- Posted by the FDA
- Oct 6, 2016
- Recalling firm
- Baxter Corporation Englewood
- Quantity
- 202,647
- Product code
- LHI
- FDA submissions
- K900585
- Distribution
- Worldwide Distribution - US (Nationwide) and countries of: Austria, Belgium, Czech Republic, Denmark, Finland, Germany, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and United Kingdom.
Product description
0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Code information (models, lots, serial numbers)
All unexpired lots-Product Code: H93835
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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