—#83672

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.

FDA product code: BSO — Catheter, Conduction, Anesthetic
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K062005
Affected lot / code info: Lot # 1579258

Why it was recalled

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.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 10 Bowman Dr, Keene, New Hampshire 03431-5043

Distribution

Distribution pattern: Nationwide Distribution -- including states of New York, Texas, Ohio, Utah, Alabama, Arizona, Kentucky, & Wyoming.

Timeline

Recall initiated: 2009-07-15
Posted by FDA: 2009-09-03
Terminated: 2012-09-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #83672. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.