Recall Z-1607-2011 ยท ITX Transducer, Ultrasonic, Diagnostic
Civco Medical Instruments Inc
CIVCO Latex Free NeoGuard Transducer Cover, Ref 676-117, Sterile (2.6 x 30cm) cover, packaged 24/box. The firm name on the label is CIVCO, Kalona, IA.
| Date | Mar 8, 2011 (initiated Jan 21, 2011) |
| Status | Terminated |
| Reason | Non-sterile transducer covers were incorrectly labeled as sterile and contained incorrect temperature storage information. |
| Root cause | Labeling design |
| Action | 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. |
| Quantity | 31/24-cover boxes |
| Distribution | Nationwide Distribution -- WA, CA, and MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013721 | SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER CIVCO Medical Instruments Co., Inc., Dec 28, 2001 |