FDAFDA · Food and drugs·Recall number Z-1852-2018
BOX PST03533 KIT APP STAPLER Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.
Published May 23, 2018 · Recall initiated: April 26, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- COVIDIEN MEDTRONIC
- Distributor
- Worldwide and US Nationwide
- Lot
- Lots: 0214860061, 0215036240, 0215036239, 0215036238, 0215018854, 0215018855, 0215102248, 0215102247, 0215068747, 0215068748, 0215050427, 0215102246, 0215050429, 0215050428, 0215068746, 0215117409, 0215117411, 0215117410, 0215125963, 0215125962, 0215125964, 0215275313, 0215275315, 0215275314, 0215282505, 0215282506
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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