Home / Recalls / Maquet Cardiovascular Us Sales, Llc / Z-0633-2021

Z-0633-2021 Class II Terminated

Recalled by Maquet Cardiovascular Us Sales, Llc — Wayne, NJ

Recall Details

Product Type
Devices
Report Date
December 23, 2020
Initiation Date
November 20, 2020
Termination Date
November 7, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.

Reason for Recall

The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Australia, Austria, Belgium, Brazil, Brunei Darussal, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malaysia, Mexico, Moldavia, Montenegro, Morocco, Myanmar, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand,Turkey, United Arab Emirates, United Kingdom, Vietnam.

Code Information

Model Number: BEQ-HLS 7050 Part Number: 70105.2794 UDI Code: 04037691773513 Lot Codes: 70130364, 70132269, 70133476, 70133592, 70133623, 70133624, 70133625, 70134790, 70135038

Other recalls by Maquet Cardiovascular Us Sales, Llc

  • Z-0632-2021 Class II — HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Cod (November 20, 2020)
  • Z-0443-2021 Class II — Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monit (September 30, 2020)
  • Z-0133-2021 Class II — Yuno II Mobile Operating Table - Product Usage: support and position the patient (September 24, 2020)
  • Z-0132-2021 Class II — Yuno Mobile Operating Table - Product Usage: Intended for support and position t (September 24, 2020)
  • Z-2957-2020 Class III — Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instr (August 7, 2020)
  • Z-2780-2020 Class II — Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygen (June 18, 2020)
  • Z-1603-2020 Class II — Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039 (February 20, 2020)
  • Z-1475-2020 Class II — Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and dr (February 10, 2020)
  • Z-1390-2020 Class III — Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product (January 16, 2020)
  • Z-1391-2020 Class III — Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product (January 16, 2020)