Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Ca...
Reason for Recall / 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.
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Mchenry |
| State | IL |
| Event id | 99100 |
| Address 1 | 1101 Corporate Dr |
| Address 2 | N/A |
| 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 |
| Postal code | 60050-7006 |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 82900 |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260605 |
| Initial firm notification | Letter |
| Center classification date | 20260701 |
Overview
- Recalling FirmMedela Inc
- StatusOngoing
- Risk LevelClass II
- DistributionUS distribution to the following states: AZ, CA, CO, FL, HI, IL, IN, MD, MI, MN, MO, NC, NJ, NY, OR, PA, TX, VA.