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.
FDA Recall Z-2050-2009 · Posted 2009-09-03
Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeBSO
Date Initiated2009-07-15
Date Terminated2012-09-14
Product Quantity190 kits (19 cases)
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.
Firm Action
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
Distribution Pattern
Nationwide Distribution -- including states of New York, Texas, Ohio, Utah, Alabama, Arizona, Kentucky, & Wyoming.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.