FDA Medical Device Recalls (openFDA)
C.R. Bard, Inc., Urological Division: Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc., Covington, GA 30014, USA.
- Recall number
- Z-1539-2009
- Recalling firm
- C.R. Bard, Inc., Urological Division
- Product
- Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc., Covington, GA 30014, USA.
- Status
- Terminated
- Initiated
- 2009-04-02
- Posted
- 2009-06-29
- Terminated
- 2009-12-04
- Reason
- The affected units may contain extension sets with the microbore tubing instead of extension sets with the macrobore tubing.
- Root cause
- 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
- 16,100 units
- Distribution
- Nationwide Distribution - including states of AZ, CA, CO, GA, IA, MN, NE, and TX.
- Lot, serial or model codes
- Lot #JUSJF441.
- 510(k) numbers
- ["K980992"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 1018233
- Firm city
- Covington
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28