Ventra Percutaneous Intravenous Catheter Repair Kit for 9 French Dual-Lumen External Catheter Segment, Reorder Number 21
FDA device recall Z-1067-03 · posted 2003-07-30 · Terminated
Recall details
- Recalling firm
- Deltec, Inc
- Reason for recall
- Silicone adhesive in kits used to repair damaged catheters did not set (cure) properly and remained in a tacky state.
- Action taken
- A recall letter, sent to the consignees on July 8, 2003, gave them the option of returning the kits or waiting for the firm to provide them with replacement silicone adhesive.
- Root cause
- Other
- Status
- Terminated
- Product code
- FOZ
- Distribution
- The product was shipped to 14 consignees (hospitals) in California, Illinois, Kansas, Michigan, Minnesota, Missouri, Pennsylvania, and Texas.
- Date initiated
- 2003-07-08
- Date posted
- 2003-07-30
- Date terminated
- 2004-07-02
- Location
- St Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KIT (K904334) | Pharmacia Deltec, Inc. | 1990-11-05 |