Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C...
FDA Device Recall #Z-0724-2017 — Class II — November 9, 2016
Recall Summary
| Recall Number | Z-0724-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 9, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Halyard Health, Inc |
| Location | Alpharetta, GA |
| Product Type | Devices |
| 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
Lot / 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)
Other Recalls from Halyard Health, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1429-2018 | Class II | Halyard Closed Suction System for Adults, Multi... | Feb 7, 2018 |
| Z-1427-2018 | Class II | Halyard Closed Suction System for Adults, Doubl... | Feb 7, 2018 |
| Z-1428-2018 | Class II | Halyard Closed Suction System for Adults, Turbo... | Feb 7, 2018 |
| Z-1277-2018 | Class II | CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) F... | Dec 13, 2017 |
| Z-0117-2018 | Class II | Halyard Closed Suction System for Adults with B... | Oct 6, 2017 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.