Z-0166-04

Portex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine...

Name: Z-0166-04 Portex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine...
Creator: Portex Inc
Published: 2003-10-10
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-10-10 / Terminated / root cause: labeling and UDI

FDA source

Portex Inc began a recall of Portex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine, Lidocaine in Dextrose and Tetracaine Catalog Number... on 2003-10-10. The reason FDA records is "Spinal trays labeled as containing a Whitacre 25g x 3.5' needle actually contain a Quincke 25g x 3.5' needle". 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-0166-04
Status: Terminated
Initiated: 2003-10-10
Posted: 2003-11-27
Terminated: 2006-05-02
Recalling firm: Abbott Medical
Product: Portex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine, Lidocaine in Dextrose and Tetracaine Catalog Number: 15545-20
Product code: CAZ Anesthesia Conduction Kit
Reason for recall: Spinal trays labeled as containing a Whitacre 25g x 3.5' needle actually contain a Quincke 25g x 3.5' needle.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Portex notified consignees on 10/10/03 by letter issued by Federal Express. Distributors were asked to supply customer list to Portex or to notify their accounts with copy of the recall letter provided.
Quantity in commerce: 2600 units
Product codes and lots: Lot number: K203631 Exp. Date: 2004-08

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)