Reported May 23, 2018 · Terminated
Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Item Code 030450) Product Usage: The Endo GIA…
Covidien Medtronic
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: COVIDIEN MEDTRONIC · 60 NIDDLETOWN AVE 2ND F · NORTH HAVEN, CT · 06473
Is this the product you have?
- Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm (
- Item Code 030450) Product UsageThe 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
- Lot codes and dates
- LotsN7L0306KX, N7M0221KX, N8B0724KX, N8C0958KX, N8C1303KRX GTIN # 1 (Inner Carton) -GTIN #1 10884523002812 GTIN # 2 (Outer Carton)- GTIN # 2 20884523002819
- Amount recalled
- 171,271 units in total
This recall covers 40 products
The agency filed one notice per product. You are reading one of them; the other 39 are below.
27 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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