| Class 2 Device Recall StatLock Intravenous (IV) Catheter Stabilization Kit | |
Date Initiated by Firm | April 02, 2009 |
Date Posted | June 29, 2009 |
Recall Status1 |
Terminated 3 on December 04, 2009 |
Recall Number | Z-1539-2009 |
Recall Event ID |
52046 |
510(K)Number | K980992 |
Product Classification |
Intravascular Administration Set - Product Code FPA
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Product | Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc., Covington, GA 30014, USA. |
Code Information |
Lot #JUSJF441. |
Recalling Firm/ Manufacturer |
C.R. Bard, Inc., Urological Division 8195 Industrial Blvd Ne Covington GA 30014-1497
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For Additional Information Contact | Mary Mayo 770-784-6120 |
Manufacturer Reason for Recall | The affected units may contain extension sets with the microbore tubing instead of extension sets with the macrobore tubing. |
FDA Determined Cause 2 | Process control |
Action | All consignees were notified by an Urgent: Product Recall Notification letter via Fed-Ex carrier on 04/02/2009. They were instructed not to use or further distribute any of the affected products. They were advised to check their inventory and to remove and return affected product to Bard Medical Division. A Recall & Effectiveness Check Form was included to be filled out and returned via fax, to Bard. |
Quantity in Commerce | 16,100 units |
Distribution | Nationwide Distribution - including states of AZ, CA, CO, GA, IA, MN, NE, and TX. |
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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510(K) Database | 510(K)s with Product Code = FPA
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