Recall Z-0724-2017— Halyard Health, Inc

Name: FDA recall Z-0724-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-09

Class II · Terminated

Class II FDA medical device recall by Halyard Health, Inc, initiated 2016-11-09, terminated 2017-02-22. It names one FDA 510(k) clearance: K862801. 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.. Reason: 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..

Recalling firm: Halyard Health, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-11-09
Terminated: 2017-02-22
Firm location: Alpharetta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K862801 — SPUNGUARD PLUS SURGICAL DRAPEKimberly-Clark Corp.·cleared 1986-08-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.