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U.S. Department of Health and Human Services

Class 3 Device Recall Baxter VLINK Luer Activated Device with Vitalshield NonDEHP Catheter Extension Set Kit

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 Class 3 Device Recall Baxter VLINK Luer Activated Device with Vitalshield NonDEHP Catheter Extension Set Kitsee related information
Date Initiated by FirmSeptember 17, 2010
Date PostedNovember 15, 2010
Recall Status1 Terminated 3 on October 04, 2011
Recall NumberZ-0351-2011
Recall Event ID 56792
Product Classification Device, vein stabilization - Product Code LBJ
ProductBaxter V-Link Luer Activated Device with Vitalshield Protective Coating Non-DEHP Catheter Extension Set Kit; 7.6" (19.3 cm), Vol. 1.0 mL, 1 Catheter Extension Set with Luer Activated Device with Silver for IV Access and Male Luer Lock Adapter with Retractable Collar, 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 6N8220
Code Information catalog 6N8220, lot numbers R09L05048, R09L08018, R09L08125, R09L17076, R09L17258 and R10A26142
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake IL 60073
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer 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.
FDA Determined
Cause 2		Component design/selection
ActionBaxter 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 Commerce73,350 units
DistributionNationwide Distribution: Throughout the US.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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