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U.S. Department of Health and Human Services

Class 2 Device Recall CSection Drape with Clear Screen or Pouch

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  Class 2 Device Recall CSection Drape with Clear Screen or Pouch see related information
Date Initiated by Firm November 09, 2016
Date Posted December 08, 2016
Recall Status1 Terminated 3 on February 22, 2017
Recall Number Z-0724-2017
Recall Event ID 75683
510(K)Number K862801  
Product Classification Drape, surgical - Product Code KKX
Product Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with Clear Screen and Full Incise (Sterile), Product Code 44966 00; C-Section Drape with Clear Screen (Non-Sterile), Product Code 44967 NS; C-Section Drape with Clear Screen (Sterile), Product Code 44968 00; C-Section Drape with Pouch and Fenestration (Non-Sterile), Product Code 44977 NS; C-Section Drape with Pouch and Fenestration (Sterile), Product Code 44978 00

Product Usage:
A surgical drape is a device made of natural or synthetic materials intended to be use as a protective patient covering, such as to isolate a site or surgical incision from microbial and other contamination.
Code Information Product Code 44965 NS - Lot Numbers AC6174###, AC62266###, AC6229###, AC6243###, AC6252###; Product Code 44966 00 - Lot Numbers AC6146##L, AC6157##L, AC6177##L, AC6215##L, AC6221##L, AC6228##L, AC6245##L, AC6252##L, AC6258##L, AC6272##L, AC6277##L; Product Code 44967 NS - Lot Numbers AC6170###, AC6219###, AC6223###, AC6229###, AC625###; Product Code 44068 00 - Lot Numbers AC6146##L, AC6177##L, AC6230##L, AC6231##L, AC6234##L, AC6242##L, AC6245##L, AC6264##L, AC6271##L, AC6277##L; Product Code 44077 NS - Lot Numbers AC6170###, AC6213###, AC6214###, AC6222###, AC6223###, AC6251###; Product Code 44978 00 - Lot Numbers AC6147##L, AC6177##L, AC6243##L, AC 6252##L - (# = includes numbers 0, 1, 2, 3, 4, 5, 6, 7, 8 or 9 - L = includes letters a, b, or c)
Recalling Firm/
Manufacturer		 Halyard Health, Inc
5405 Windward Pkwy
Alpharetta GA 30004-3894
For Additional Information Contact Thomas Kozma, PhD
470-448-3004
Manufacturer Reason
for Recall		 Drapes within the affected lots may include a manufacturing variation that prevents convenient removal of the coated release paper, which inhibits easy access to the surgical site.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Accounts were notified of the recall by letter on 11/9/2016. The consignees were instructed to quarantine and discontinue use of the recalled lots and to discard/destroy per the facility's standard disposal procedure for nonwoven materials. A response form was included which was to be sent back.
Quantity in Commerce 132 cases
Distribution US Nationwide Distribution in the states of AL, FL, GA, IL, KS, MN, MO, NE, NJ, OH, PH, TN, VA, WI, WY
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.
510(K) Database 510(K)s with Product Code = KKX and Original Applicant = KIMBERLY-CLARK CORP.
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