Portex Continuous Epidural Tray, Reference 4037-20 An anesthesia conduction kit is a device used to administer to a pati
FDA device recall Z-2050-2009 · posted 2009-09-03 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- Portex Continuous Epidural Tray was distributed with a 20G closed end, three eyed, nylon catheter without a stylet instead of the 20 G open end Teflon catheter with stylet specified on the label.
- Action taken
- Smiths Medical notified consignees by an Urgent Device Recall letter dated July 15, 2009, to locate and quarantine the affected product, stop distribution, and complete and fax back the attached Distributor Reply Letter to Smiths Medical. Credit or replacement will be arranged as requested for the return of any affected product. All distributors will be required to return any affected product in stock. All of the distributors will be required to send their customer list to Smiths Medical who will notify their customers of this recall.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- BSO
- Quantity affected
- 190 kits (19 cases)
- Distribution
- Nationwide Distribution -- including states of New York, Texas, Ohio, Utah, Alabama, Arizona, Kentucky, & Wyoming.
- Date initiated
- 2009-07-15
- Date posted
- 2009-09-03
- Date terminated
- 2012-09-14
- Location
- Keene, NH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PORTEX EPIDURAL CATHETER (K062005) | Smiths Medical Asd, Inc. | 2006-10-18 |