Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc., Covington, GA 30014, USA.
FDA Recall Z-1539-2009 · Posted 2009-06-29
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Recalling FirmC.R. Bard, Inc., Urological Division
Recall StatusTerminated
Product CodeFPA
Date Initiated2009-04-02
Date Terminated2009-12-04
Product Quantity16,100 units
Reason for Recall
The affected units may contain extension sets with the microbore tubing instead of extension sets with the macrobore tubing.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution - including states of AZ, CA, CO, GA, IA, MN, NE, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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