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U.S. Department of Health and Human Services

Class 3 Device Recall Bard Davol Reliavac

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  Class 3 Device Recall Bard Davol Reliavac see related information
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/
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
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.