Ethicon Endo-Surgery Inc Recall: ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm s
Ethicon Endo-Surgery Inc Recall: ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm s is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Ethicon Endo-Surgery Inc; Product: ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A; Reason for recall: The stap
| Recalling firm | Ethicon Endo-Surgery Inc |
|---|---|
| Product | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A |
| Reason for recall | 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. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Terminated |
| Distribution | Worldwide distribution. US Nationwide. Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore. |
| Recall initiated | 20191003 |
| Recall number | Z-0201-2020 |
| Category | device |
| State | OH |
| Country | United States |
$29/mo
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