Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc., Covington, GA 30014
FDA device recall Z-1539-2009 · posted 2009-06-29 · Terminated
Recall details
- Recalling firm
- C.R. Bard, Inc., Urological Division
- Reason for recall
- The affected units may contain extension sets with the microbore tubing instead of extension sets with the macrobore tubing.
- Action taken
- 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
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 16,100 units
- Distribution
- Nationwide Distribution - including states of AZ, CA, CO, GA, IA, MN, NE, and TX.
- Date initiated
- 2009-04-02
- Date posted
- 2009-06-29
- Date terminated
- 2009-12-04
- Location
- Covington, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES (K980992) | Venetec Intl., Inc. | 1998-05-28 |