Z-0352-2011

Baxter V-Link Luer Activated Device with VitalShield Protective Coating Non-DEHP Catheter Extension Set Kit...

Name: Z-0352-2011 Baxter V-Link Luer Activated Device with VitalShield Protective Coating Non-DEHP Catheter Extension Set Kit...
Creator: Baxter Healthcare Corp.
Published: 2010-09-17
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2010-09-17 / Terminated / root cause: design

FDA source

Baxter Healthcare Corp. began a recall of Baxter V-Link Luer Activated Device with VitalShield Protective Coating Non-DEHP Catheter Extension Set Kit; 8.2" (21.0 cm), Vol. 0.5 mL, 1 Catheter Extension... on 2010-09-17. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0352-2011
Status: Terminated
Initiated: 2010-09-17
Posted: 2010-11-15
Terminated: 2011-10-04
Recalling firm: Baxter Healthcare Corporation
Product: Baxter V-Link Luer Activated Device with VitalShield Protective Coating Non-DEHP Catheter Extension Set Kit; 8.2" (21.0 cm), Vol. 0.5 mL, 1 Catheter Extension St with luer activated device with silver for IV Access and Male Luer Lock Adapter, 1 VITAL-HOLD medium catheter stabilization device, 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 6N8222
Product code: LBJ Device, Vein Stabilization
Reason for recall: 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 tag: design
FDA 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 in commerce: 1,000 units
Distribution: Nationwide Distribution: Throughout the US.
Product codes and lots: catalog 6N8222, lot numbers R10A30052 and R10B13049

Product code LBJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)