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Terminated

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

FDA Recall Z-1523-05 · Posted 2005-09-08

Recalling FirmNorth Coast Medi-Tek Inc
Recall StatusTerminated
Product CodeLRO
Date Initiated2004-06-23
Date Terminated2007-02-21
Product Quantity70 cases, each case containing 5 devices.

Reason for Recall

Product contains the incorrect lot number.

Firm 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.

Root Cause

Other

Distribution Pattern

The product was distributed to one domestic consignee: E-Z-EM, 717 Main Street, Westbury, NY 11590.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K854095BIOPSY TRAY I & IINorth Coast Medi-Tek · 1985-11-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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