Z-0724-2017 Class II Terminated
FDA device recall Z-0724-2017 was initiated by Halyard Health, Inc on November 9, 2016 and is designated Class II. 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. The recall status is terminated (terminated February 22, 2017). Affected quantity: 132 cases.
Recall Details
- Product Type
- Devices
- Report Date
- December 14, 2016
- Initiation Date
- November 9, 2016
- Termination Date
- February 22, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 132 cases
Product Description
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.
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.
Distribution Pattern
US Nationwide Distribution in the states of AL, FL, GA, IL, KS, MN, MO, NE, NJ, OH, PH, TN, VA, WI, WY
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)