FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Baxter Interlink System Minivolume Extension Set, product code 1C8462; An Rx sterile, nonpyrogenic fluid pathway, 16.0'', 4.2 mL Vol., with 2 injection sites, 0.22 Micron Downstream High Pressure Extended Life Filter and male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
- Recall number
- Z-0641-06
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Baxter Interlink System Minivolume Extension Set, product code 1C8462; An Rx sterile, nonpyrogenic fluid pathway, 16.0'', 4.2 mL Vol., with 2 injection sites, 0.22 Micron Downstream High Pressure Extended Life Filter and male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
- Status
- Terminated
- Initiated
- 2005-12-15
- Posted
- 2006-03-24
- Terminated
- 2008-08-18
- Reason
- The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Root cause
- Other
- Action
- Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots and product codes via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.
- Quantity
- 4,272 sets
- Distribution
- Nationwide, including Puerto Rico and American Samoa, and internationally to Canada, Australia, Japan, South Korea, Saudi Arabia, India, Mexico, Venezuela, Malaysia, East Timor and New Zealand.
- Lot, serial or model codes
- product code 1C8462, lots GR227140, GR230664, GR231852, GR224659
- 510(k) numbers
- ["K925126","K964850"]
- 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