Ultrasound probe cover, sterile. Catalog No. 910811.
FDA device recall Z-1571-05 · posted 2005-09-21 · Terminated
Recall details
- Recalling firm
- North Coast Medi-Tek Inc
- Reason for recall
- Customer observed unsealed packages.
- Action taken
- The recalling firm called their customer and requested the customer to return un-sealed packages.
- Root cause
- Other
- Status
- Terminated
- Product code
- KKX
- Quantity affected
- 30 cases containing 10 units per case.
- Distribution
- The product was distributed to one consignee: Cone Instruments, 5210 Naiman Parkway, Solon, OH 44139.
- Date initiated
- 2005-06-07
- Date posted
- 2005-09-21
- Date terminated
- 2007-12-17
- Location
- Mentor, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICROTEK EQUIPMENT DRAPES (K050322) | Microtek Medical, Inc. | 2005-05-17 |