FDA Recalls 3.1 Million Covidien EGIA 45 Articulating Xtra Thick Sulu Devices
The FDA is recalling 3,113,280 units of the EGIA 45 Articulating Xtra Thick Sulu device due to a missing pin component that may cause incomplete staple formation and serious medical complications.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect that can lead to serious medical complications such as sepsis, peritonitis, and pneumothorax, meeting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 3,113,280 units of the EGIA 45 Articulating Xtra Thick Sulu, Item Code EGIA45AXT, manufactured by Covidien LLC. The recall is due to a defect where the device may be missing one of two pin components that maintain the alignment of the device jaws.
This defect can result in incomplete staple formation during use. Incomplete stapling may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax, which can result in the potential for infection and/or sepsis. The affected devices were distributed nationwide in the United States and worldwide in foreign markets.
The recall number is Z-1827-2019. The source text does not specify specific lot numbers or dates, but identifies the product by the item code EGIA45AXT. Healthcare providers and facilities should stop using the affected devices and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
- Manufacturer
- Covidien LLC
- Affected units
- 3,113,280
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- N6B0080KX N6C0975KX
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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