In March 2022, the FDA announced a recall of the Avanos Medical Cortrak*2 Enteral Access System. In light of this recall, ASPEN reminds the community of ASPEN documents on safe nasoenteric feeding tube placement and verification for adult and pediatric patients. These best practice recommendations apply to blind insertions and placements with an electromagnetic device and include evidence-based recommendations.
Update: This recall does NOT require any customer to physically return product. Please see Avanos’ response to inquiries about the Avanos CORTRAK* 2 Voluntary Field Correction here.
Please note: In the paper labeled adult, on Table 4, under EMPD Only Cortrak (Avanos) is FDA approved for verification. In the column labeled Advantages, the following language Cortrak is FDA approved for verification of tube tip but may need to consider a second method of confirmation if indicated should be substituted with Confirmation of NG/NI tubes placed with CORTRAK*2 should be confirmed per institutional protocol as per a April 22, 2022 FDA granted 510(k) clearance for labeling change.