Z-0511-03

Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8516 and 1M8516Y; Baxter...

Name: Z-0511-03 Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8516 and 1M8516Y; Baxter...
Creator: Baxter Healthcare Corp.
Published: 2002-10-17
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2002-10-17 / Terminated / root cause: labeling and UDI

FDA source

Baxter Healthcare Corp. began a recall of Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8516 and 1M8516Y; Baxter Healthcare Corporation, Auto Syringe Division... on 2002-10-17. The reason FDA records is "The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0511-03
Status: Terminated
Initiated: 2002-10-17
Posted: 2003-02-06
Terminated: 2004-02-04
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8516 and 1M8516Y; Baxter Healthcare Corporation, Auto Syringe Division, Hookset, NH 03106
Product code: FPA Set, Administration, Intravascular
Reason for recall: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Recalled by letter dated 10/17/02. Accounts were informed of the potential for the filters to be 1.2 micron filters instead of the 0.22. micron filters as labeled. The accounts were requested to examine their inventories for the affected catalog numbers and destroy the units found for credit.
Quantity in commerce: 16,860 units
Distribution: Nationwide, Australia, Puerto Rico, Brazil, Canada, Sweden, New Zealand, Japan, Mexico, American Samoa, El Salvador, Turkey, Saudi Arabia, Austria, Cayman Islands, Macedonia, Honduras, Kuwait, Hong Kong and Nigeria.
Product codes and lots: All lots received prior to 10/23/2002

Product code FPA

K811078Class IIRadiation Sterilized Admin. SetTravenol Laboratories, S.A. / cleared 1981-07-02

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)