CIVCO Latex Free NeoGuard Transducer Cover, Ref 676-117, Sterile (2.6 x 30cm) cover, packaged 24/box. The firm name on t
FDA device recall Z-1607-2011 · posted 2011-03-08 · Terminated
Recall details
- Recalling firm
- Civco Medical Instruments Inc
- Reason for recall
- Non-sterile transducer covers were incorrectly labeled as sterile and contained incorrect temperature storage information.
- Action taken
- The recalling firm notified their customers via phone and e-mail letter entitled Urgent - Medical Device Correction, dated 1/21/11, explaining the reason for recall. The letter stated that the firm will replace the affected product and requested that customers dispose of the product from the affected lots. A response form was enclosed to report final disposition of the product and should be returned to the firm. If there are any questions, customers can call their customer service representative at 800-445-6741 between 8 am and 5 pm CST.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- ITX
- Quantity affected
- 31/24-cover boxes
- Distribution
- Nationwide Distribution -- WA, CA, and MO.
- Date initiated
- 2011-01-21
- Date posted
- 2011-03-08
- Date terminated
- 2013-07-09
- Location
- Kalona, IA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER (K013721) | CIVCO Medical Instruments Co., Inc. | 2001-12-28 |