Smiths Medical ASD, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Smiths Medical ASD, Inc.
Lot Codes / Batch Numbers
Lot # 1579258
Products Sold
Lot # 1579258
Smiths Medical ASD, Inc. is recalling Portex Continuous Epidural Tray, Reference 4037-20 An anesthesia conduction kit is a device used to due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026