Premicath 28G PICC Catheter
FDA device recall Z-0090-06 · posted 2005-10-28 · Terminated
Recall details
- Recalling firm
- Vygon Corporation
- Reason for recall
- Guidewire protuding from tip of the catheter
- Action taken
- The recalling firm issued a recall letter via fax to the distributors on 6/27/05. The letter informed the distributors of the problem and to notify any hospital accounts of the problem and the need to trim the catheter prior to implantation.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 243 units
- Distribution
- The product was shipped to distributors in CA, CO, FL, IL, MD, NJ, NY, OH, PA, TX and WA.
- Date initiated
- 2005-06-27
- Date posted
- 2005-10-28
- Date terminated
- 2005-10-31
- Location
- Norristown, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PREMICATH, 1261.205 (K041468) | Vygon Corp. | 2004-09-09 |