ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A
- Company
- Ethicon Endo-Surgery Inc
- Recall Initiated
- October 3, 2019
- Posted
- October 29, 2019
- Terminated
- June 3, 2021
- Recall Number
- Z-0200-2020
- Quantity
- 849 units
- Firm Location
- Blue Ash, OH
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.
Distribution
Worldwide distribution. US Nationwide. Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore.
Lot / Code Info
Lot: T9408M, T94899, T94A9Z
Root Cause
Nonconforming Material/Component
Action Taken
Urgent Medical Device Recall (Removal) letters were sent to customers beginning 10/3/19. The letters instruct customers to do the following: ACTION REQUIRED: 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2. Remove the product subject to this voluntary recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 4. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax or email it to Stericycle at 1-866-300-3432 or ethicon7148@stericycle.com within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 5. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Stericycle. While processing your returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your records. 6. Customers are required to return unused impacted ECHELON FLEX ENDOPATH 60mm Staplers subject to this recall that are in their inventory immediately. To receive replacement product, customers must return product subject to this recall by December 31, 2019. Any nonaffected product and any product returned after the date specified will not be replaced. 7. To return product subject to this recall, photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Ethicon will pay for the shipping charges only if the authorized label is used. Extra shipping labels may be obtained by calling Stericycle at 1-866-918-8756. Your account n