Z-0711-04

AngioDynamics Incorporated 21 Gauge Micro Access Needle, B-Bevel - 4 cm length, catalog No. 06506803

Name: Z-0711-04 AngioDynamics Incorporated 21 Gauge Micro Access Needle, B-Bevel - 4 cm length, catalog No. 06506803
Creator: Enpath Medical, Inc.
Published: 2004-02-26
License: https://open.fda.gov/license/

Greatbatch Medical / initiated 2004-02-26 / Terminated / root cause: labeling and UDI

FDA source

Enpath Medical, Inc. began a recall of AngioDynamics Incorporated 21 Gauge Micro Access Needle, B-Bevel - 4 cm length, catalog No. 06506803 on 2004-02-26. The reason FDA records is "The product is labeled as sterile product but had not been sterilized". 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-0711-04
Status: Terminated
Initiated: 2004-02-26
Posted: 2004-07-20
Terminated: 2006-06-25
Recalling firm: Greatbatch Medical
Product: AngioDynamics Incorporated 21 Gauge Micro Access Needle, B-Bevel - 4 cm length, catalog No. 06506803
Product code: GAA Needle, Aspiration And Injection, Disposable
Reason for recall: The product is labeled as sterile product but had not been sterilized.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The only direct consignee, to whom the product was shipped, was notified of the recall by telephone and fax on February 26, 2004. The consignee was requested to the return the product and to sub-recall the product from their customers.
Quantity in commerce: 20 ten-pack kits
Distribution: All of the product was shipped to a distributor in New York.
Product codes and lots: Lot W24005, Use By 2005-03

Product code GAA

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)