EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
Reported: June 26, 2019 Initiated: May 17, 2019 #Z-1827-2019
Product Description
EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
Reason for Recall
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
Details
- Recalling Firm
- Covidien LLC
- Units Affected
- 3,113,280
- Distribution
- Nationwide domestic distribution, worldwide foreign distribution.
- Location
- North Haven, CT
Frequently Asked Questions
What product was recalled? ▼
EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT. Recalled by Covidien LLC. Units affected: 3,113,280.
Why was this product recalled? ▼
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 26, 2019. Severity: Moderate. Recall number: Z-1827-2019.
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