ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm recall
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A
Why was ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm recalled?
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
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?
Lot: T93Z1G, T93Y4M, T94045, T94117, T93X17, T94087, T93Z2X, T9405L, T94253, T93X95, T93Z75, T93Z2W, T9413Z
- Product
- ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A
- Recalling firm
- Ethicon Endo-Surgery Inc
- Quantity
- 5040 units
- Distribution
- Worldwide distribution. US Nationwide. Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore.
- Recall date
- November 6, 2019
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)