Devices

Device Recall Halyard

  • 모델명 / 제조번호(시리얼번호)
    Product Description, Product code:   a. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN), 227;  b. HALYARD* TRACH CARE-72 DSE ENDO 14FR, 227-5;  c. HALYARD* TRACH CARE-72 WET PAK* 14FR, 22701356-5;  d. HALYARD* TRACH CARE-72 WET PAK* T-PIECE SWVL/FLEX ENDO 14FR, 2270156-5;  e. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5 CM (GREEN), 22703;  f. HALYARD* TRACH CARE-72 DSE TRACH 14FR, 22703-5;  g. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 14FR, 227036-5;  h. HALYARD* TRACH CARE-72 DSE ENDO 10FR, 227101-5;  i. HALYARD* TURBO-CLEANING 10FR DSE 12IN/30.5CM (BLACK), 2271013;  j. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 10FR, 2271018-5;  k. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 12FR, 2271218-5;  l. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE), 22712183;  m. HALYARD* 72 DSE MDI BUILT IN ENDO 12FR, 22712186-5;  n. HALYARD* 72 DSE TRACH CARE 12FR, 227121863-5;  o. HALYARD* 14FR DSE 22.2IN/56CM (GREEN), 2271418;  p. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 14FR, 2271418-5;  q. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5CM (GREEN), 22714183;  r. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 14FR, s. 22714183-5;  s. HALYARD* TC-72 WET PAK* DSE MDI ENDO 14FR, 22714186;  t. HALYARD* TC-72 WET PAK DSE MDI ENDO 14FR, 22714186-5;  u. HALYARD* TC-72 WET PAK DSE 14FR, 227141863-5;  v. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN), 227147;  w. HALYARD* TURBO-CLEANING 12FR DSE 21.3IN/54 CM (WHITE), 22716;  x. HALYARD* TRACH CARE-72 DSE ENDO 12FR, 22716-5;  y. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE), 2271603;  z. HALYARD* TRACH CARE-72 DSE TRACH 12FR, 2271603-5;  aa. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 12FR, 22716036-5;  ab. HALYARD* TURBO-CLEANING 16FR DSE 21.3IN/54CM (ORANGE), 227161;  ac. HALYARD* TRACH CARE-72 DSE 16FR 21.3IN/54CM, 227161-5;  ad. HALYARD* TRACH CARE-72 DSE TRACH 16FR, 2271613-5;  ae. HALYARD* TRACH CARE-72 DSE ENDO 16FR, 2271616-5;  af. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 16FR, ag. 2271618-5;  ag. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 16FR, 22716183-5;  ah. HALYARD* TRACH CARE-72 DSE MDI ENDO 16FR, 22716186-5;  ai. HALYARD* TRACH CARE-72 DSE 16FR, 227161863-5;  aj. HALYARD* TRACH CARE-72 WET PAK* DSE ENDO 12FR, 227166-5;  ak. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN), 2276;  al. HALYARD* TURBO-CLEANING 14FR DSE Endo, 2276-5;
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Double¿Swivel¿Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. || a. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN); || b. HALYARD* TRACH CARE-72 DSE ENDO 14FR; || c. HALYARD* TRACH CARE-72 WET PAK* 14FR; || d. HALYARD* TRACH CARE-72 WET PAK* T-PIECE SWVL/FLEX ENDO 14FR; || e. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5 CM (GREEN); || f. HALYARD* TRACH CARE-72 DSE TRACH 14FR; || g. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 14FR; || h. HALYARD* TRACH CARE-72 DSE ENDO 10FR; || i. HALYARD* TURBO-CLEANING 10FR DSE 12IN/30.5CM (BLACK); || j. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 10FR; || k. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 12FR; || l. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE); || m. HALYARD* 72 DSE MDI BUILT IN ENDO 12FR; || n. HALYARD* 72 DSE TRACH CARE 12FR; || o. HALYARD* 14FR DSE 22.2IN/56CM (GREEN); || p. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 14FR; || q. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5CM (GREEN); || r. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 14FR; || s. HALYARD* TC-72 WET PAK* DSE MDI ENDO 14FR; || t. HALYARD* TC-72 WET PAK DSE MDI ENDO 14FR; || u. HALYARD* TC-72 WET PAK DSE 14FR; || v. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN); || w. HALYARD* TURBO-CLEANING 12FR DSE 21.3IN/54 CM (WHITE); || x. HALYARD* TRACH CARE-72 DSE ENDO 12FR; || y. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE); || z. HALYARD* TRACH CARE-72 DSE TRACH 12FR; || aa. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 12FR; || ab. HALYARD* TURBO-CLEANING 16FR DSE 21.3IN/54CM (ORANGE); || ac. HALYARD* TRACH CARE-72 DSE 16FR 21.3IN/54CM; || ad. HALYARD* TRACH CARE-72 DSE TRACH 16FR; || ae. HALYARD* TRACH CARE-72 DSE ENDO 16FR; || af. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 16FR; || ag. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 16FR; || ah. HALYARD* TRACH CARE-72 DSE MDI ENDO 16FR; || ai. HALYARD* TRACH CARE-72 DSE 16FR; || aj. HALYARD* TRACH CARE-72 WET PAK* DSE ENDO 12FR; || ak. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN); || al. HALYARD* TURBO-CLEANING 14FR DSE Endo;
  • Manufacturer
    Halyard Health, Inc
  • 1 Event

제조사

Halyard Health, Inc
  • 제조사 주소
    Halyard Health, Inc, 5405 Windward Pkwy, Alpharetta GA 30004-3894
  • Source
    USFDA

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Device Recall Halyard
  • 모델명 / 제조번호(시리얼번호)
    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)
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • Manufacturer
    Halyard Health, Inc
Device Recall Halyard
  • 모델명 / 제조번호(시리얼번호)
    Product Description, Product code:   a. HALYARD* MULTI-PORT, DSY, ENDO 10FR, 24010-5;  b. HALYARD* MULTI-PORT, DSY, ENDO 12FR, 240121-5;  c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR, 240128-5;  d. HALYARD* MULTI-PORT, DSY, ENDO 14FR, 24014-5;  e. HALYARD* MULTI-PORT, DSY, TRACH 14FR, 240143-5;  f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR, 2401436-5;  g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR, 2401438-5;  h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR, 240146-5;  i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR, 240146-5N;  j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR, 240148-5;  k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR, 240168-5;   j. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 10FR, 2271018-5;  k. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 12FR, 2271218-5;  l. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE), 22712183;  m. HALYARD* 72 DSE MDI BUILT IN ENDO 12FR, 22712186-5;  n. HALYARD* 72 DSE TRACH CARE 12FR, 227121863-5;  o. HALYARD* 14FR DSE 22.2IN/56CM (GREEN), 2271418;  p. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 14FR, 2271418-5;  q. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5CM (GREEN), 22714183;  r. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 14FR, s. 22714183-5;  s. HALYARD* TC-72 WET PAK* DSE MDI ENDO 14FR, 22714186;  t. HALYARD* TC-72 WET PAK DSE MDI ENDO 14FR, 22714186-5;  u. HALYARD* TC-72 WET PAK DSE 14FR, 227141863-5;  v. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN), 227147;  w. HALYARD* TURBO-CLEANING 12FR DSE 21.3IN/54 CM (WHITE), 22716;  x. HALYARD* TRACH CARE-72 DSE ENDO 12FR, 22716-5;  y. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE), 2271603;  z. HALYARD* TRACH CARE-72 DSE TRACH 12FR, 2271603-5;  aa. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 12FR, 22716036-5;  ab. HALYARD* TURBO-CLEANING 16FR DSE 21.3IN/54CM (ORANGE), 227161;  ac. HALYARD* TRACH CARE-72 DSE 16FR 21.3IN/54CM, 227161-5;  ad. HALYARD* TRACH CARE-72 DSE TRACH 16FR, 2271613-5;  ae. HALYARD* TRACH CARE-72 DSE ENDO 16FR, 2271616-5;  af. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 16FR, ag. 2271618-5;  ag. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 16FR, 22716183-5;  ah. HALYARD* TRACH CARE-72 DSE MDI ENDO 16FR, 22716186-5;  ai. HALYARD* TRACH CARE-72 DSE 16FR, 227161863-5;  aj. HALYARD* TRACH CARE-72 WET PAK* DSE ENDO 12FR, 227166-5;  ak. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN), 2276;  al. HALYARD* TURBO-CLEANING 14FR DSE Endo, 2276-5;
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids from a patient's upper airway. || a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; || b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; || c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR; || d. HALYARD* MULTI-PORT, DSY, ENDO 14FR; || e. HALYARD* MULTI-PORT, DSY, TRACH 14FR; || f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR; || g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; || h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; || i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; || j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; || k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR;
  • Manufacturer
    Halyard Health, Inc