Recall Z-1572-05 ยท LRO General Surgery Tray
North Coast Medi-Tek Inc
SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11-07, packaged as 10 trays per case.
| Date | Sep 21, 2005 (initiated Jan 18, 2005) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K854095 | BIOPSY TRAY I & II North Coast Medi-Tek, Nov 25, 1985 |