Z-0942-03

Temno Chiba FIne Needle Aspiration, Soft Tissue Biopsy Needle, 18 GA x 15 cm., product CHI1815, Allegiance, a...

Name: Z-0942-03 Temno Chiba FIne Needle Aspiration, Soft Tissue Biopsy Needle, 18 GA x 15 cm., product CHI1815, Allegiance, a...
Creator: Cardinal Health
Published: 2003-06-02
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2003-06-02 / Terminated / root cause: sterility

FDA source

Cardinal Health began a recall of Temno Chiba FIne Needle Aspiration, Soft Tissue Biopsy Needle, 18 GA x 15 cm., product CHI1815, Allegiance, a Cardinal Health Company, McGaw Park, IL 60085... on 2003-06-02. The reason FDA records is "The product was shipped prior to being sterilized". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0942-03
Status: Terminated
Initiated: 2003-06-02
Posted: 2003-06-12
Terminated: 2003-09-08
Recalling firm: Medtronic, Inc.
Product: Temno Chiba FIne Needle Aspiration, Soft Tissue Biopsy Needle, 18 GA x 15 cm., product CHI1815, Allegiance, a Cardinal Health Company, McGaw Park, IL 60085 USA, Made in Dominican Republic
Product code: KNW Instrument, Biopsy
Reason for recall: The product was shipped prior to being sterilized.
Root cause tag: sterility
FDA root cause: Other
Action: Recalled by telephone call and follow-up letter on 6/2/03. The accounts were informed that the biopsy needles were not sterile, and were requested to examine their inventory for the affected lot and return any found for credit and replacement.
Quantity in commerce: 50 needles
Distribution: Florida, Georgia, Minnesota, Oklahoma, Ohio, Missouri and internationally to Malaysia.
Product codes and lots: Catalog number CHI1815, lot D03AB0594

Product code KNW

K962907Class IISkinny,franseen,wescott NeedlesBaxter Healthcare Corp / cleared 1996-10-23

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)