Z-0211-2007

Portex Continuous Epidural tray Ref 4948-17

Name: Z-0211-2007 Portex Continuous Epidural tray Ref 4948-17
Creator: Smiths Medical ASD, Inc.
Published: 2006-10-27
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-10-27 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical ASD, Inc. began a recall of Portex Continuous Epidural tray Ref 4948-17 on 2006-10-27. The reason FDA records is "Misbranded: Tray label states 26G x 5/8 inch, needle is 25 G x 1 inch". 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-0211-2007
Status: Terminated
Initiated: 2006-10-27
Posted: 2006-11-22
Terminated: 2012-05-22
Recalling firm: Abbott Medical
Product: Portex Continuous Epidural tray Ref 4948-17
Product code: CAZ Anesthesia Conduction Kit
Reason for recall: Misbranded: Tray label states 26G x 5/8 inch, needle is 25 G x 1 inch
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Smith Medical notified Dealers and direct customers contacted via letter delivered by Federal Express on October 27, 2006. Customers of dealers will be notified upon receipt of the dealer customer list.
Quantity in commerce: 540 units
Distribution: Nationwide and Panama
Product codes and lots: Lot Number: 1063342

Product code CAZ

K965017Class IIRegional Anesthesia TraysSmiths Industries Medical Systems, Inc. / cleared 1997-03-14

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)