Date Initiated by Firm | September 17, 2010 |
Date Posted | November 15, 2010 |
Recall Status1 |
Terminated 3 on October 04, 2011 |
Recall Number | Z-0353-2011 |
Recall Event ID |
56792 |
Product Classification |
Device, vein stabilization - Product Code LBJ
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Product | Baxter Catheter Stabilization Device; 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 2N8200 |
Code Information |
catalog 2N8200, lot numbers R10A20137, R10A21101 and R10B05052 |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corp. Rt. 120 & Wilson Rd Round Lake IL 60073
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For Additional Information Contact | Center 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 |
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 | 63,650 units |
Distribution | Nationwide Distribution: Throughout the US. |
Total Product Life Cycle | TPLC Device Report |
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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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