FDAFDA · Food and drugs·Recall number Z-1515-2024
EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00566471
Published April 17, 2024 · Recall initiated: February 20, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Worldwide distribution - US Nationwide and the country of Japan.
- Lot
- GTIN: 08714729802631 Lot Numbers: 32295181 , 32295182 , 32306054 , 32306055 , 32316800 , 32323673 , 32342013 ,32367049 , 32367050 , 32374782 , 32472868 , 32486230 , 32486231 , 32486232 , 32486233 , 32506056 , 32515039 , 32523243 , 32523244 , 32531793 , 32531794 , 32531795 , 33113026 , 33113027 , 33113028 , 33113029 , 33170338
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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