Ethicon Endo-Surgery Recalls Echelon Vascular White Reloads Due to Staple Line Defect
Ethicon Endo-Surgery is recalling 6,744 Echelon Vascular White Reloads because an internal inspection found a production issue that may cause the cartridge to deploy an incomplete staple line.
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. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects in medical devices, are classified as Severe (4). An incomplete staple line in a surgical instrument represents a significant functional defect with potential for serious patient harm.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 6,744 units of the ENDOPATH ECHELON Vascular White Reload for Advanced Placement Tip. The recall was initiated after an internal inspection of the production process identified an issue that may cause the cartridge to deploy an incomplete staple line.
The affected devices are used in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. The recall covers specific product lots with expiry dates ranging from November 2017 to January 2018.
The devices were distributed worldwide, including nationwide in the United States across 32 states and in Hong Kong. Healthcare providers and facilities should stop using the affected lots and contact the recalling firm for further instructions.
The recalled product
- Product
- ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures.
- Manufacturer
- Ethicon Endo-Surgery Inc
- Affected units
- 6,744
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 (18)
- M/N: VASECR35
- Product Lot L4FF3W
- Expiry Date 2017-11
- Product Lot L4FF3X
- Product Lot L4FF3Y
- Product Lot M4H046
- Expiry Date 2017-12
- Product Lot M4H105
- Product Lot M4H27D
- Product Lot M4H30H
- Product Lot M4H37J
- Product Lot M4H399
- Product Lot M4H589
- Expiry Date 2018-01
- Product Lot M4H54M
- Product Lot M4H643
- Expiry Date 2018-01 & Product Lot M4H691
- Expiry Date 2018-01..
Distribution
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