Halyard Closed Suction System for Adults recall
Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. Labeled as…
Why was Halyard Closed Suction System for Adults recalled?
Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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)
- Product
- Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. Labeled as…
- Recalling firm
- Halyard Health, Inc
- Quantity
- 32,189 cases (20 units per case - 643,780 units) total
- Distribution
- 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.
- Recall date
- April 25, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)