Recall Z-1568-05 ยท GBX Catheter, Irrigation
C.R. Bard, Inc., Urological Division
Bard * Davol Reliavac 400 Closed Wound Suction Kit * Sterile/EO * Single use * Medium-Large 3/16'' (15 Fr., 4.7mm) O.D. PVC Drain * 12.5'' (31.7cm) Hole Pattern, X-ray Opaque Stripe Attached Trocar * 400cc Evacuator ** Y-Connecting Tube * * C.R. Bard Inc., Covington, GA 30014. The product contains a 400cc Evacuator, Y-connector with drainage tube and a 3/116 PVC drain with trocar. These components
| Date | Sep 21, 2005 (initiated Aug 17, 2005) |
| Status | Terminated |
| Reason | An incorrect Y-connector was placed in the kit. |
| Root cause | Other |
| Action | Consignees were notified by letter on/about 08/17/2005 |
| Quantity | 360 units |
| Distribution | AL, CA, FL, GA, IL, IN, NJ, TN, TX, Belgium and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.