SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.
FDA Recall Z-1099-2019 · Posted None
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Recalling FirmLivaNova USA Inc.
Recall StatusTerminated
Product CodeDWC
Date Initiated2018-09-14
Date Terminated2022-09-14
Product Quantity6 devices
Reason for Recall
For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
Firm Action
The recalling firm, LivaLova, contacted the first customer by phone on 9/14/2018 followed by an "IMPORT" letter, the first of which was dated 9/18/2018. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: keep these devices out of service until the investigation is complete. To return your device, please email [email protected].
If taking Serial Numbers 16S15335 and 16S15337 out of service will negatively impact your clinical practice, we can arrange for delivery of loaner devices during this investigation and,as necessary, while they undergo repeat Deep Cleaning Process.
If you have any questions, contact V.P., Clinical, Quality, and Regulatory Services at 303-467-6306 or email: [email protected].
Root Cause
Material/Component Contamination
Distribution Pattern
US Distribution to states of: IN, MO, and OH.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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