FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Baxter Interlink System Continu-Flo Solution Set with Large Bore 4-Way Stopcock Extension Set, 10 drops/mL, product code 3C0062s; a sterile, nonpyrogenic fluid pathway for administration of IV fluids; Manufactured by an affiliate of Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in Costa Rica
- Recall number
- Z-0943-05
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Baxter Interlink System Continu-Flo Solution Set with Large Bore 4-Way Stopcock Extension Set, 10 drops/mL, product code 3C0062s; a sterile, nonpyrogenic fluid pathway for administration of IV fluids; Manufactured by an affiliate of Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in Costa Rica
- Status
- Terminated
- Initiated
- 2005-04-21
- Posted
- 2005-06-30
- Terminated
- 2006-07-19
- Reason
- There is an unsecure connection between the male Luer and the stopcock on the I.V. extension set.
- Root cause
- Other
- Action
- Recall letters dated 4/21/05 were sent to the direct accounts via first class mail on the same date to the attention of the Director of Materials Management. The accounts were informed of the reports of an unsecure connection between the male luer and the stopcock due to silicone on the male luer tip, and were requested to examine their inventory for the affected lots of product, and call Baxter Healthcare Center for Service at 1-888-229-001 to return the affected product for credit.
- Quantity
- 107,832 sets
- Distribution
- Nationwide and internationally to American Samoa and Venezuela.
- Lot, serial or model codes
- product code 3C0062s, lot numbers R04D28173, R04D28181, R04D28199, R04F22288, R04F23237, R04F25273, R04G24100, R04G26071, R04H12020, R04H13085, R04H13242, R04H30303, R04I21151, R04J06227, R04J07076, R04J07092, R04J28122, R04K08064, R04K08221, R04K26090, R04K29086, R04L09110, R04L17055, R04L17188, R04L18137, R05A20092, R05A20217, R05B03187, R05B04060, R05B28192
- 510(k) numbers
- ["K022895"]
- PMA numbers
- not on file
- Product code
- FMG
- 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