Z-2050-2009

Portex Continuous Epidural Tray, Reference 4037-20 An anesthesia conduction kit is a device used to...

Name: Z-2050-2009 Portex Continuous Epidural Tray, Reference 4037-20 An anesthesia conduction kit is a device used to...
Creator: Smiths Medical ASD, Inc.
Published: 2009-07-15
License: https://open.fda.gov/license/

Abbott Medical / initiated 2009-07-15 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical ASD, Inc. began a recall of Portex Continuous Epidural Tray, Reference 4037-20 An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local... on 2009-07-15. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2050-2009
Status: Terminated
Initiated: 2009-07-15
Posted: 2009-09-03
Terminated: 2012-09-14
Recalling firm: Abbott Medical
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.
Product code: BSO Catheter, Conduction, Anesthetic
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.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
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.
Quantity in commerce: 190 kits (19 cases)
Distribution: Nationwide Distribution -- including states of New York, Texas, Ohio, Utah, Alabama, Arizona, Kentucky, & Wyoming.
Product codes and lots: Lot # 1579258

Product code BSO

K062005Class IIPortex Epidural CatheterSmiths Medical Asd, Inc. / cleared 2006-10-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)