Z-1523-05

E-Z-EM brand, Basic biopsy tray, catalog no. 4125

Name: Z-1523-05 E-Z-EM brand, Basic biopsy tray, catalog no. 4125
Creator: North Coast Medi-Tek Inc
Published: 2004-06-23
License: https://open.fda.gov/license/

North Coast Medi-Tek / initiated 2004-06-23 / Terminated

FDA source

North Coast Medi-Tek Inc began a recall of E-Z-EM brand, Basic biopsy tray, catalog no. 4125 on 2004-06-23. The reason FDA records is "Product contains the incorrect lot number". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1523-05
Status: Terminated
Initiated: 2004-06-23
Posted: 2005-09-08
Terminated: 2007-02-21
Recalling firm: North Coast Medi-Tek
Product: E-Z-EM brand, Basic biopsy tray, catalog no. 4125.
Product code: LRO General Surgery Tray
Reason for recall: Product contains the incorrect lot number.
FDA root cause: Other
Action: The recalling firm sent revised correct labels, containing the correct lot number, to the consignee which were affixed to the box containing the device.
Quantity in commerce: 70 cases, each case containing 5 devices.
Distribution: The product was distributed to one domestic consignee: E-Z-EM, 717 Main Street, Westbury, NY 11590.
Product codes and lots: Lot number 0324 on the package. The correct lot number is 0424.

Product code LRO

K854095Class IIBiopsy Tray I & IINorth Coast Medi-Tek / cleared 1985-11-25

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)