Maquet Cardiovascular Us Sales, Llc: Medical Device Recall in 2020 - (Recall #: Z-2780-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal / Pediatric oxygenator and is being used as a single holder for QUADROX i and QUADROX iD Neonatal / Pediatric Oxygenator and can also be used in combination with the holder's arm (016061) to use in cardiopulmonary bypass procedures (CPB) in a pediatric patient population.

Product Classification:

Class II

Date Initiated: June 18, 2020

Date Posted: August 19, 2020

Recall Number: Z-2780-2020

Event ID: 86020

Reason for Recall:

Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediatric Oxygenator. The Holder may not always snap and securely hold the oxygenator as intended.

Status: Terminated

Product Quantity: 50 units

Code Information:

Model Number: 701047495 Part Number: HKHZ 19 UDI Code: 04037691533339 Lot# 70128207

Distribution Pattern:

Worldwide distribution - US Nationwide distribution including in the states of OH, PA, SC, CT and the countries of Germany, Spain, France, United Kingdom, Italy, United Arab Emirates, Mexico, Canada, Croatia, Georgia, Poland, Slovakia, Thailand, and Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated