FDA Medical Device Recalls (openFDA)
North Coast Medi-Tek Inc: SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11-07, packaged as 10 trays per case.
- Recall number
- Z-1572-05
- Recalling firm
- North Coast Medi-Tek Inc
- Product
- SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11-07, packaged as 10 trays per case.
- Status
- Terminated
- Initiated
- 2005-01-18
- Posted
- 2005-09-21
- Terminated
- 2007-02-21
- Reason
- Outside box labeling, containing 10 trays, incorrectly identified the product as ultrasound trays. Product is Breast Biopsy trays, Cat. 255826R2. Individual tray package labeling correctly identifies the product as Breast Biopsy tray.
- Root cause
- Other
- Action
- The recalling firm sent corrected labels to the distributor for the labeling of all 5 cases that were on hand.
- Quantity
- 5 cases, each case containing 10 kits (50 total kits).
- Distribution
- The product was distributed to one customer: Source One Healthcare Technologies distribution center, 4434 Mulhauser Road #300, Hamilton, OH 45011.
- Lot, serial or model codes
- Lot number 0503, expiration date 11-07.
- 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