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U.S. Department of Health and Human Services

Class 2 Device Recall Halyard

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  Class 2 Device Recall Halyard see related information
Date Initiated by Firm February 07, 2018
Create Date April 18, 2018
Recall Status1 Terminated 3 on January 18, 2022
Recall Number Z-1427-2018
Recall Event ID 79531
Product Classification Catheters, suction, tracheobronchial - Product Code BSY
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 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
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)
Recalling Firm/
Manufacturer		 Halyard Health, Inc
5405 Windward Pkwy
Alpharetta GA 30004-3894
For Additional Information Contact Thomas Kozma, Ph.D.
470-448-5681
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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