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U.S. Department of Health and Human Services

Class 2 Device Recall Bard RespiShield

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  Class 2 Device Recall Bard RespiShield see related information
Date Initiated by Firm September 28, 2005
Date Posted November 23, 2005
Recall Status1 Terminated 3 on January 25, 2006
Recall Number Z-0178-06
Recall Event ID 33780
Product Classification Catheters, Suction, Tracheobronchial - Product Code BSY
Product Bard RespiShield¿ * Closed Suction System with InnoValve¿ * Endotracheal Start Kit * QTY 1 Unit * 14F/4.7mm * Sterile * Rx Only * C.R.Bard, Inc., Covington, GA 30014, 800-526-4455, www. bardmedical.com * Manufactured in Mexico.
Code Information Catalog Number: 220059, Lot Numbers: NGPD0713, NGPD0714, NGPE11, Catalog Number: 220067, Lot Number: NGPD2781, Catalog Number: 220068, Lot Number: NGPD0855, Catalog Number: 220069, Lot Numbers: NGPD0939, NGPD1735, NGPD2015, NGPE0403, NGPE0404, Catalog Number: 220141, Lot Number: NGPE1200, Catalog Number: 220145, Lot Number: NGPD0934, Catalog Number: 220155, Lot Number: NGPD2697, Catalog Number: 220211, Lot Number: NGPE1170.
Recalling Firm/
Manufacturer		 C.R. Bard, Inc., Urological Division
8195 Industrial Blvd Ne
Covington GA 30014-1497
For Additional Information Contact Frances E. Harrison, RAC
770-784-6257
Manufacturer Reason
for Recall		 Varying degrees of difficulty were encountered when opening and closing the InnoValve.
FDA Determined
Cause 2		 Other
Action Consignees were notified via Federal Express letter on/about 09/28/2005.
Quantity in Commerce 10169 units
Distribution Nationwide
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.
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