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 number

Z-2050-2009

Recalling firm

Smiths Medical ASD, Inc.

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.

Status

Terminated

Initiated

2009-07-15

Posted

2009-09-03

Terminated

2012-09-14

Reason

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

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

190 kits (19 cases)

Distribution

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

Lot, serial or model codes

Lot # 1579258

510(k) numbers

["K062005"]

PMA numbers

not on file

Product code

BSO

Firm FEI

1217052

Firm city

Keene

Firm state

NH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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