Z-0251-06

A1378-18 Portex Epidural Mini-pack

Name: Z-0251-06 A1378-18 Portex Epidural Mini-pack
Creator: Smiths Medical ASD, Inc.
Published: 2005-11-17
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-11-17 / Terminated / root cause: packaging

FDA source

Smiths Medical ASD, Inc. began a recall of A1378-18 Portex Epidural Mini-pack on 2005-11-17. The reason FDA records is "Tray may contain holes compromising the sterility of the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0251-06
Status: Terminated
Initiated: 2005-11-17
Posted: 2005-11-30
Terminated: 2012-05-08
Recalling firm: Abbott Medical
Product: A1378-18 Portex Epidural Mini-pack
Product code: CAZ Anesthesia Conduction Kit
Reason for recall: Tray may contain holes compromising the sterility of the device
Root cause tag: packaging
FDA root cause: Other
Action: Smiths Medical ASD notffied accounts by letter via UPS or Fedex on November 17, 2005. Customers and dealers are directed to fax back the attached Reply Letter to Smiths Medical, Keene even if the customer/dealer no longer has affected products in inventory
Distribution: Nationwide
Product codes and lots: Lot Numbers: 012383, 101306, 106641, 111202, K128822, K141918, K147447, K171974, K207397, K511073, K558479, K658947

Product code CAZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)