Medela Inc: Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medela Inc
- 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
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US distribution to the following states: AZ, CA, CO, FL, HI, IL, IN, MD, MI, MN, MO, NC, NJ, NY, OR, PA, TX, VA.
- Recall initiated
- 2026-06-05
- Code info
- 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
- Product quantity
- 82900
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Mchenry
- State
- IL
- Country
- United States
- Event id
- 99100
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