Z-1572-05

SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11-07, packaged as 10...

Name: Z-1572-05 SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11-07, packaged as 10...
Creator: North Coast Medi-Tek Inc
Published: 2005-01-18
License: https://open.fda.gov/license/

North Coast Medi-Tek / initiated 2005-01-18 / Terminated / root cause: labeling and UDI

FDA source

North Coast Medi-Tek Inc began a recall of SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11-07, packaged as 10 trays per case on 2005-01-18. The reason FDA records is "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...". 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-1572-05
Status: Terminated
Initiated: 2005-01-18
Posted: 2005-09-21
Terminated: 2007-02-21
Recalling firm: North Coast Medi-Tek
Product: SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11-07, packaged as 10 trays per case.
Product code: LRO General Surgery Tray
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Lot number 0503, expiration date 11-07.

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)