Recall Z-1527-2018 ยท GDW Staple, Implantable
Covidien LLC
EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 20884521047515 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed for use as a stapler instrument for control of rectal prolapse and hemorrhoid disease. The instrument places a circular, dou
| Date | Apr 9, 2018 |
| Status | Terminated |
| Reason | There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak. |
| Root cause | Nonconforming Material/Component |
| Action | Notification letters were distributed on 4/9/18. The letters instructed customers to: Medtronic requests that you quarantine and return any unused products of the item codes and lots detailed above. Unused products from the affected item codes and lots should be returned as described in the Required Actions section below. If you have distributed Covidien EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology listed above, please promptly forward the information from this letter to those recipients. All unused products from the affected item codes and lots must be returned. Req |
| Quantity | 5547 |
| Distribution | Worldwide Distribution - US Nationwide in the US states of : AL, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, SC, TN, TX, UT, and VA. The devices were distributed to the following foreign countries: UAE, Australia, Austria, Belgium, Bulgaria, Canada, Czech Re |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083781 | EEA HEMORRHOID STAPLER & ACCESSORIES Surgical Devices, A Global Business Unit Covidien, Feb 4, 2009 |