Halyard Health, Inc: Halyard Closed Suction System for Adults, Turbo- cleaningClosedSuctionSystemforAdults,DoubleSwivelElbow (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;

Recall number

Z-1428-2018

Recalling firm

Halyard Health, Inc

Product

Halyard Closed Suction System for Adults, Turbo- cleaningClosedSuctionSystemforAdults,DoubleSwivelElbow (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;

Status

Terminated

Initiated

2018-02-07

Posted

not on file

Terminated

2022-01-18

Reason

Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.

Root cause

Labeling design

Action

Customers were notified via mail and/or email on about 02/07/2018. Instructions for distributors included to notify all affected customers who may have received potentially impacted products and to complete and return the Distributor Acknowledgement Form. Instructions for customers included to ensure adequate connection of the Flex Connector to Swivel Connector before use of the product by following. This accomplished by ensuring a tight fit is achieved on the Swivel with the Flex Connector advanced approximately three-quarters over the Swivel, so a gap remains visible. If and adequate connection is observed, the Flex Connector may be replaced with a new, sterile Flex Connector and the system connection should be re-evaluated. Lastly, if use of a Flex Connector with the ventilator circuit is optional, the closed suction Swivel Connector can be connected directly to the ventilator circuit. During use, if a disconnection between the Flex Connector and Swivel Connector is observed during use, replace the Flex Connector with a new, sterile Flex Connector (e.g. HYH Product # 1115) and ensure adequate connection as described in this notice. If an inadequate connection occurs, Halyard Health instructs customers to safe the Flex Connector and report it via the Product Complaint Process (PIQ) and the local Halyard Health Sales Representative will assist. Additionally customers were instructed to complete and return the Acknowledgement Form and distribute the recall notice to all clinicians in the facility that may be impacted.

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.

Lot, serial or model codes

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;

510(k) numbers

not on file

PMA numbers

not on file

Product code

BSY

Firm FEI

3011270181

Firm city

Alpharetta

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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