Z-0007-2017Class I

0.2 Micron Filter, 50 mm

Name: Z-0007-2017 0.2 Micron Filter, 50 mm
Creator: Baxter Corporation Englewood
Published: 2016-08-24
License: https://open.fda.gov/license/

Baxter Corporation Englewood / initiated 2016-08-24 / Terminated / root cause: manufacturing process

FDA source

Baxter Corporation Englewood began a recall of 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... on 2016-08-24. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0007-2017
Classification: Class I
Status: Terminated
Initiated: 2016-08-24
Posted: 2016-10-06
Terminated: 2017-07-26
Recalling firm: Baxter Corporation Englewood
Product: 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.
Product code: LHI Set, I.V. Fluid Transfer
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 202,647
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 codes and lots: All unexpired lots-Product Code: H93835

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0007-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0007-2017	Class I	Terminated	Voluntary: Firm initiated	2016-10-12	2016-10-06

Product code LHI

K900585Class IITubing Sets for Baxa Exacta-Med Pharmacy PumpBaxa Corp., Sub. of Cook Group, Inc. / cleared 1990-04-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)