FDA Medical Device Recalls (openFDA)
North Coast Medi-Tek Inc: E-Z-EM brand, Basic biopsy tray, catalog no. 4125.
- Recall number
- Z-1523-05
- Recalling firm
- North Coast Medi-Tek Inc
- Product
- E-Z-EM brand, Basic biopsy tray, catalog no. 4125.
- Status
- Terminated
- Initiated
- 2004-06-23
- Posted
- 2005-09-08
- Terminated
- 2007-02-21
- Reason
- Product contains the incorrect lot number.
- 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
- 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.
- Lot, serial or model codes
- Lot number 0324 on the package. The correct lot number is 0424.
- 510(k) numbers
- ["K854095"]
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1526414
- Firm city
- Mentor
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28