Consumer Alerts Tracker
openFDA Medical device

Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Product Description: Enteral Extension Set, Length 60 Orange-Striped Minibore Tubing, (Approx. Priming Vol. 2.00 mL), ENFit¿ Component: N/A

May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.

Official details

Category
Medical device recall
Status
Ongoing
Classification
Class II
Company or vendor
Medela Inc
Affected product
US distribution to the following states: AZ, CA, CO, FL, HI, IL, IN, MD, MI, MN, MO, NC, NJ, NY, OR, PA, TX, VA.
Risk or reason
May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.
Remedy or action
Lot Code: Item Number ENF060182LD / 101033086; Lot Number 0000747253; Date of Manufacturing 2026-01-16; Expiration Date 2029-01-16; Carton GTIN 20020451101358; Unit GTIN 00020451101354
Official ID
Z-2645-2026