Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or ...
FDA Device Recall #Z-1427-2018 — Class II — February 7, 2018
Recall Summary
| Recall Number | Z-1427-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 7, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Halyard Health, Inc |
| Location | Alpharetta, GA |
| Product Type | Devices |
| Quantity | 32,189 cases (20 units per case - 643,780 units) total |
Product Description
Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. Labeled as the following: a. HALYARD* 12FR DSE 21.3IN/54CM (WHITE); b. HALYARD* 12 FR TRACH CARE DSE ENDO; c. HALYARD* 12FR DSE 12IN/30.5CM (WHITE); d. HALYARD* 12FR TRACH CARE DSE TRACH; e. HALYARD* 14FR DSE 21.3IN/54CM (GREEN); f. HALYARD* 14FR TRACH CARE DSE ENDO; g. HALYARD* 14FR DSE 12IN/30.5CM (GREEN); h. HALYARD* 14FR TRACH CARE DSE TRACH; i. HALYARD* 14FR DSE 12IN/30.5CM; j. HALYARD* 14FR TRACH CARE WET PAK* DSE MDI TRACH; k. HALYARD* 14FR TRACH CARE WET PAK* DSE ENDO; l. HALYARD* 14FR TRACH CARE WET PAK* DSE DIR TIP ENDO; m. HALYARD* 14 FR TRACH CARE DSE DUAL LUMEN ENDO; n. HALYARD* 14FR TRACH CARE DSE MDI ENDO; o. HALYARD* 14FR DSE 22.2IN/56 CM (GREEN); p. HALYARD* 14FR TRACH CARE DSE DIR TIP ENDO; q. HALYARD* 16FR DSE 21.3IN/54CM (ORANGE); r. HALYARD* 16FR TRACH CARE DSE ENDO; s. HALYARD* 16FR TRACH CARE WET PAK* DSE ENDO
Reason for Recall
Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.
Distribution Pattern
Worldwide distribution. US nationwide including Puerto Rico, ARGENTINA, AUSTRALIA, BAHAMAS, BELGIUM, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REP., ECUADOR, EL SALVADOR, GUATEMALA, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, LEBANON, MALAYSIA, MEXICO, NEW ZEALAND, PERU, PHILIPPINES, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, THAILAND, UNITED KINGDOM, and UNITED ARAB EMIRATES.
Lot / Code Information
Product Description, (Product code): a. HALYARD* 12FR DSE 21.3IN/54CM (WHITE), (2160); b. HALYARD* 12 FR TRACH CARE DSE ENDO, (2160-5); c. HALYARD* 12FR DSE 12IN/30.5CM (WHITE), (21603); d. HALYARD* 12FR TRACH CARE DSE TRACH, (21603-5); e. HALYARD* 14FR DSE 21.3IN/54CM (GREEN), (22108130, 2210, 22106, 22107, 22108, 22108147, 8224); f. HALYARD* 14FR TRACH CARE DSE ENDO, (2210-5); g. HALYARD* 14FR DSE 12IN/30.5CM (GREEN), (22103, 221037, 221038, 8223, 221036); h. HALYARD* 14FR TRACH CARE DSE TRACH, (22103-5); i. HALYARD* 14FR DSE 12IN/30.5CM, (221036-5); j. HALYARD* 14FR TRACH CARE WET PAK* DSE MDI TRACH, (2210386-5); k. HALYARD* 14FR TRACH CARE WET PAK* DSE ENDO, (22106-5); l. HALYARD* 14FR TRACH CARE WET PAK* DSE DIR TIP ENDO, (221069-5); m. HALYARD* 14 FR TRACH CARE DSE DUAL LUMEN ENDO, (22107-5); n. HALYARD* 14FR TRACH CARE DSE MDI ENDO, (22108-5); o. HALYARD* 14FR DSE 22.2IN/56 CM (GREEN), (22108148, 22109); p. HALYARD* 14FR TRACH CARE DSE DIR TIP ENDO, (22109-5); q. HALYARD* 16FR DSE 21.3IN/54CM (ORANGE), (2260, 22606); r. HALYARD* 16FR TRACH CARE DSE ENDO, (2260-5); s. HALYARD* 16FR TRACH CARE WET PAK* DSE ENDO, (22606-5)
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-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 |
| Z-0122-2018 | Class II | Halyard Closed Suction System for Adults, 14 F,... | 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.