Portex Continuous Epidural Tray, Reference 4037-20 An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia.
This recall has been terminated (originally issued September 3, 2009).
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- July 15, 2009
- Posted
- September 3, 2009
- Terminated
- September 14, 2012
- Recall Number
- Z-2050-2009
- Quantity
- 190 kits (19 cases)
- Firm Location
- Keene, NH
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution -- including states of New York, Texas, Ohio, Utah, Alabama, Arizona, Kentucky, & Wyoming.
Lot / Code Info
Lot # 1579258
Root Cause
Mixed-up of materials/components
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.