| Class 2 Device Recall ContinuFlo Solution Set with Large Bore 4Way Stopcock Extension Set |  |
Date Initiated by Firm | April 21, 2005 |
Date Posted | June 30, 2005 |
Recall Status1 |
Terminated 3 on July 19, 2006 |
Recall Number | Z-0943-05 |
Recall Event ID |
31800 |
510(K)Number | K022895 |
Product Classification |
Stopcock, I.V. Set - Product Code FMG
|
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 |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corp. Rt. 120 & Wilson Rd Round Lake IL 60073
|
For Additional Information Contact | Center for One Baxter 800-422-9837 |
Manufacturer Reason for Recall | There is an unsecure connection between the male Luer and the stopcock on the I.V. extension set. |
FDA Determined Cause 2 | 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 in Commerce | 107,832 sets |
Distribution | Nationwide and internationally to American Samoa and Venezuela. |
Total Product Life Cycle | TPLC 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.
|
510(K) Database | 510(K)s with Product Code = FMG
|
|
|
|