Z-1278-04

4965-25 Spinal(shb)whitacre W/drugs

Name: Z-1278-04 4965-25 Spinal(shb)whitacre W/drugs
Creator: Smiths Medical ASD, Inc.
Published: 2004-07-02
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-07-02 / Terminated

FDA source

Smiths Medical ASD, Inc. began a recall of 4965-25 SPINAL(SHB)WHITACRE W/DRUGS on 2004-07-02. The reason FDA records is "Trays contain Hospira recalled 2ml drug ampuls of 5% Lidocaine Hydrochloride with 7.5% Dextrose Injection, (NDC 0074-4712-01, lot number 09-568-DK) Hospira, Inc. was recalling the 2ml drug vials of 5% Lidocaine...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1278-04
Status: Terminated
Initiated: 2004-07-02
Posted: 2004-07-30
Terminated: 2006-05-02
Recalling firm: Abbott Medical
Product: 4965-25 Spinal(shb)whitacre W/drugs
Product code: CAZ Anesthesia Conduction Kit
Reason for recall: Trays contain Hospira recalled 2ml drug ampuls of 5% Lidocaine Hydrochloride with 7.5% Dextrose Injection, (NDC 0074-4712-01, lot number 09-568-DK) Hospira, Inc. was recalling the 2ml drug vials of 5% Lidocaine Hydrochloride w/ 7.5% Dextrose lot number 09-568-DK). The drug is being recalled due to reports of particulate in the product.
FDA root cause: Other
Action: Smiths Medical notifed Dealers and direct customers were contacted via letter delivered by Federal Express on July 2, 2004. Customers and dealers are directed to fax back the attached Reply Letter
Quantity in commerce: 870 units
Distribution: Nationwide
Product codes and lots: Lot Numbers: K515841, K518985, K520198

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)