FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Baxter 60'' Micro-Volume Extension Set, catalog 2N3350; Baxter Healthcare Corporation, Deerfield, IL 60015
- Recall number
- Z-0521-03
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Baxter 60'' Micro-Volume Extension Set, catalog 2N3350; Baxter Healthcare Corporation, Deerfield, IL 60015
- Status
- Terminated
- Initiated
- 2002-10-17
- Posted
- 2003-02-06
- Terminated
- 2004-02-04
- Reason
- The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- 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
- 630,140 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.
- Lot, serial or model codes
- All lots received prior to 10/23/2002
- 510(k) numbers
- ["K791496","K860746"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 1416980
- Firm city
- Round Lake
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28