Recall StatusTerminated
Date Initiated2015-02-26
Date Terminated2015-11-17
Product Quantity6,744 devices
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.
Firm Action
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
[email protected]. 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
Distribution Pattern
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 of Hong Kong.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.