Recall Z-0720-05 ยท ITX Transducer, Ultrasonic, Diagnostic
Bard Access Systems, Inc
Site Rite II, Site Rite 3, and Site Rite IV Systems with 2 Sterile Kits each.
| Date | Apr 22, 2005 (initiated Nov 3, 2004) |
| Status | Terminated |
| Reason | Conductivity gel pouches, labeled as sterile, may not be sterile. |
| Root cause | Other |
| Action | All domestic consignees were notified by letter on 10/04/2004. All foreign consignees were notified by letter on 10/15/04. |
| Quantity | 2360 units |
| Distribution | Nationwide. Foreign distribution to: Austria; Bahrain, Belgium, Bermuda, Brazil, Canada, Greece, Hong Kong, Italy, Japan, Kuwait, Malaysia, Mexico, Norway, Oman, Pakistan, Portugal, Qatar, Saudi Arabia, Switzerland, Turkey, United Arab Emirates, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.