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Recall Observatory FDA recall evidence

Device product

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

Z-2645-2026

June 05, 2026

Class II

Product summary

Firm
Medela Inc
Event
Event 99100
Status
Ongoing
Classification
Class II
Quantity
82900
Official record key
device-enforcement:Z-2645-2026

Official wording

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.

Code information: 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

Distribution pattern: US distribution to the following states: AZ, CA, CO, FL, HI, IL, IN, MD, MI, MN, MO, NC, NJ, NY, OR, PA, TX, VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.