Maquet Holder HKHZ 19 Recalled for Insecure Oxygenator Fit
Maquet is recalling Holder HKHZ 19 units for Quadrox-i and Quadrox-iD oxygenators because the holder may not securely hold the oxygenator.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect where the holder may not securely hold the oxygenator. This is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling 50 units of Holder HKHZ 19 (Model Number: 701047495, Lot Number: 70128207). This accessory is used with QUADROX i and QUADROX iD Neonatal / Pediatric oxygenators in cardiopulmonary bypass procedures for pediatric patients.
The recall was initiated because the Holder may not always snap and securely hold the oxygenator as intended. This defect could compromise the stability of the oxygenator during use.
The affected units were distributed worldwide, including in the United States (OH, PA, SC, CT) and in Germany, Spain, France, United Kingdom, Italy, United Arab Emirates, Mexico, Canada, Croatia, Georgia, Poland, Slovakia, Thailand, and Vietnam. Users should stop using the affected holders and contact Maquet Cardiovascular for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Affected units
- 50
Distribution
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