| |
Class 3 Device Recall Bard Davol Reliavac |
 |
| Date Initiated by Firm |
August 17, 2005 |
| Date Posted |
September 21, 2005 |
| Recall Status1 |
Terminated 3 on August 21, 2009 |
| Recall Number |
Z-1568-05 |
| Recall Event ID |
33284 |
| Product Classification |
Catheter, Irrigation - Product Code GBX
|
| Product |
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 are provided together in a kit but not preassembled. |
| Code Information |
Catalog Number: 0034630, Lot Number: NGPE0150 |
Recalling Firm/
Manufacturer |
C.R. Bard, Inc., Urological Division
8195 Industrial Blvd Ne
Covington GA 30014-1497
|
| For Additional Information Contact |
Vivian Stephens
800-526-4455 Ext. 6902
|
Manufacturer Reason
for Recall |
An incorrect Y-connector was placed in the kit.
|
FDA Determined
Cause 2 |
Other |
| Action |
Consignees were notified by letter on/about 08/17/2005 |
| Quantity in Commerce |
360 units |
| Distribution |
AL, CA, FL, GA, IL, IN, NJ, TN, TX, Belgium and Japan |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|
