Recall Z-0724-2017 ยท KKX Drape, Surgical, Antimicrobial
Halyard Health, Inc
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
| Date | Dec 8, 2016 (initiated Nov 9, 2016) |
| Status | Terminated |
| 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. |
| Root cause | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K862801 | SPUNGUARD PLUS SURGICAL DRAPE Kimberly-Clark Corp., Aug 7, 1986 |