FDA-Device2018-05-23Class II
(1)LAPBARLECZNA ZESTAW BARIATRYCZNY LECZNA (2) KITBAR021- BARIATRIC KIT X1 Item Code:KITBAR021- BARIATRIC KIT X0 (3)BOX SGGLOGX1 ZESTAW DO BARIATRII Item Code: SGGLOGX1 ZESTAW DO BARIATRII (4)BOX SGGLOGX1 ZESTAW DO BARIATRII Item Coder:SGGLOGX1 ZESTAW DO BARIATRII (5)BOX SGSWP1 ZESTAW DO RESEKCJI REKAWOWEJ Item Code:SGSWP1 ZESTAW DO RESEKCJI REKAWOWEJ Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows
COVIDIEN MEDTRONIC
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.
Sold states
Worldwide and US Nationwide
Affected count
169,775 units in total
Manufactured in
60 NIDDLETOWN AVE 2ND F, NORTH HAVEN, CT, United States
Products
(1)LAPBARLECZNA ZESTAW BARIATRYCZNY LECZNA (2) KITBAR021- BARIATRIC KIT X1 Item Code:KITBAR021- BARIATRIC KIT X0 (3)BOX SGGLOGX1 ZESTAW DO BARIATRII Item Code: SGGLOGX1 ZESTAW DO BARIATRII (4)BOX SGGLOGX1 ZESTAW DO BARIATRII Item Coder:SGGLOGX1 ZESTAW DO BARIATRII (5)BOX SGSWP1 ZESTAW DO RESEKCJI REKAWOWEJ Item Code:SGSWP1 ZESTAW DO RESEKCJI REKAWOWEJ 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1843-2018Don't want to check this manually?
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