| Class 2 Device Recall CSection Drape with Clear Screen or Pouch | |
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
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = KKX
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