ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
- Company
- Ethicon Endo-Surgery Inc
- Recall Initiated
- December 11, 2023
- Posted
- January 26, 2024
- Recall Number
- Z-0834-2024
- Quantity
- 22,616 (US), 4,476 (OUS)
- Firm Location
- Blue Ash, OH
Reason for Recall
There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada and Brazil.
Lot / Code Info
UDI-DI 10705036014928 Lots 442C02 and 442C03
Root Cause
Under Investigation by firm
Action Taken
On December 11, 2023, the firm notified affected consignees through URGENT VOLUNTARY MEDICAL DEVICE RECALL (REMOVAL) letters. Customers were instructed to cease use and distribution of affected product lots. Customers should examine their inventory immediately to determine if they have affected product. Affected product should be quarantined. Unused affected product should be returned. If you require any assistance with returning product, please contact Sedgwick at 888-591-5087 and reference Event # 6925. If you have additional questions regarding this voluntary medical device recall, please contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266). The Ethicon Resource Department is open Monday through Friday, 8:00 AM to 5:00 PM ET.