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.
This recall has been terminated (originally issued June 18, 2020).
- Recall Initiated
- June 18, 2020
- Terminated
- December 30, 2022
- Recall Number
- Z-2780-2020
- Quantity
- 50 units
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
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.
Lot / Code Info
Model Number: 701047495 Part Number: HKHZ 19 UDI Code: 04037691533339 Lot# 70128207
Root Cause
Under Investigation by firm
Action Taken
Getinge sent a customer letter dated July 2020 instructing customers to remove the affected products from areas of use and return the product(s) to Getinge following the provided instructions.