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U.S. Department of Health and Human Services

Class 2 Device Recall Kendall

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  Class 2 Device Recall Kendall see related information
Date Initiated by Firm January 08, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on May 15, 2012
Recall Number Z-0382-04
Recall Event ID 28090
Product Classification Dressing, Wound, Occlusive - Product Code NAD
Product Kendall Curity Disposable Laparotomy Sponges,
12 in x 12 in, Sterile
Product Number: 6034
Code Information Lot Number: 33452700
Recalling Firm/
Kendall Healthcare Products Co
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact Gail Christie
Manufacturer Reason
for Recall
Sterility compromised due to lack of package seal integrity
FDA Determined
Cause 2
Action Kendall issued Recall letters by US Mail to all customers on January 8, 2004, requesting product be returne and dealer customers be notified.
Quantity in Commerce 188 cases
Distribution AL, AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO,NC NE, NJ, NY, OH, PA, RI, TN, TX, VA, WA, WI, WV.
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.