BOX KIT00714 KIT SLEEVE Product Usage: The Endo GIA recall
BOX KIT00714 KIT SLEEVE Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples…
Why was BOX KIT00714 KIT SLEEVE Product Usage: The Endo GIA 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots 0214915642, 0214983138, 0215159225, 0215234652
- Product
- BOX KIT00714 KIT SLEEVE Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples…
- Recalling firm
- COVIDIEN MEDTRONIC
- Quantity
- 171,271 units in total
- Distribution
- Worldwide and US Nationwide
- Recall date
- May 23, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)