SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11-07, packaged as 10 trays per
FDA device recall Z-1572-05 · posted 2005-09-21 · Terminated
Recall details
- Recalling firm
- North Coast Medi-Tek Inc
- 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.
- Action taken
- The recalling firm sent corrected labels to the distributor for the labeling of all 5 cases that were on hand.
- Root cause
- Other
- Status
- Terminated
- Product code
- LRO
- Quantity affected
- 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.
- Date initiated
- 2005-01-18
- Date posted
- 2005-09-21
- Date terminated
- 2007-02-21
- Location
- Mentor, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOPSY TRAY I & II (K854095) | North Coast Medi-Tek | 1985-11-25 |