FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Baxter CLEARLINK System, Non-DEHP Catheter Extension Set Kit; 7.7" (20.0 cm), Vol. 1.10 mL, 1 Catheter Extension Set with Luer Activated Valve for IV access and Male Luer Lock Adapter, 1 VITAL-HOLD Medium Catheter Stabilization Device with 2 foam tape strips; an Rx sterile convenience kit for IV infusions; 50 units per case; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60015 U.S.A., Made in Costa Rica; catalog 2N8220
- Recall number
- Z-0354-2011
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Baxter CLEARLINK System, Non-DEHP Catheter Extension Set Kit; 7.7" (20.0 cm), Vol. 1.10 mL, 1 Catheter Extension Set with Luer Activated Valve for IV access and Male Luer Lock Adapter, 1 VITAL-HOLD Medium Catheter Stabilization Device with 2 foam tape strips; an Rx sterile convenience kit for IV infusions; 50 units per case; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60015 U.S.A., Made in Costa Rica; catalog 2N8220
- Status
- Terminated
- Initiated
- 2010-09-17
- Posted
- 2010-11-15
- Terminated
- 2011-10-04
- Reason
- The removable paper liner covering the adhesive strip that is used to secure the catheter stabilization device to the patient is pyrogenic. The device is labeled as nonpyrogenic.
- Root cause
- Component design/selection
- Action
- Baxter issued Urgent Product Recall letters dated September 17, 2010 to the affected direct accounts. The accounts were informed that the paper lining covering the adhesive strip that is used to secure the catheter stabilization device to the patient was found to be pyrogenic. The accounts were requested to discontinue use and segregate the affected lots of products from inventory and call Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, 7:00 AM to 6:00 PM CT, to arrange for the return of the affected product for credit. The accounts were also requested to complete and fax back to Baxter the enclosed reply sheet confirming receipt of the letter and the amount of each product being returned. If the accounts further distributed the products, they were requested to forward the communication to those accounts. Clinical questions regarding the communication are directed to the Medical Information Services at Baxter at 1-800-933-0303. Any other questions may be directed to the Center for One Baxter at 1-800-422-9837.
- Quantity
- 10,000 units
- Distribution
- Nationwide Distribution: Throughout the US.
- Lot, serial or model codes
- catalog 2N8220, lot numbers R10B01119 and R10B17081
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LBJ
- 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