ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in m
FDA device recall Z-1641-2015 · posted 2015-05-21 · Terminated
Recall details
- Recalling firm
- Ethicon Endo-Surgery Inc
- Reason for recall
- During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line.
- Action taken
- Ethicon sent an Urgent Medical Device Recall letter dated February 27, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine your inventory immediately to determine if you have recalled product on hand, remove and quarantine the recalled product, communicate the issue to relevant operating room or materials management personnel or anyone else in your facility who needs to be informed, if any product included in this recall has been forwarded to another facility, contact that facility to arrange return, and complete the Business Reply Form (BRF) (Attachment B) confirming receipt of this notice within three (3) business days. The BRF may be sent to Stericycle by fax at 1-800-807-5967or by email at ees8760@stericycle.com. Please return the BRF even if you do not have affected product. For clinical or product support, please contact your local sales representative or call our Customer Support Center at 1-877-ETHICON (1-877-384-4266) (7:30 a.m. 6:30 p.m. EST). If you need additional shipping labels or a communications package, contact Stericycle at 1-877-643-8419 (8:00 a.m. 5:00 p.m. EST) and reference Event 8760.
- Root cause
- Software in the Use Environment
- Status
- Terminated
- Product code
- GDW
- Quantity affected
- 6,744 devices
- Distribution
- Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, CO, DE, FL, GA, IA, IL, KS, KY, LA, MA, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WI and the country
- Date initiated
- 2015-02-26
- Date posted
- 2015-05-21
- Date terminated
- 2015-11-17
- Location
- Blue Ash, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED (K141952) | Ethicon Endo-Surgery, Inc. | 2014-11-24 |