FDAFDA · Food and drugs·Recall number Z-2161-2020
Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)
Published June 3, 2020 · Recall initiated: March 17, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Applied Medical Resources Corp
- Distributor
- US: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY OUS: Argentina, Australia, Austria, Belgium, Canada, Chile, Costa Rica, Denmark, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Latvia, Liechtenstein, Luxembourg, Netherlands, New Zealand, Peru, Portugal, Serbia, Singapore, South Africa, Spain, Thailand, United Kingdom
- Lot
- Batch: 1380797, 1382197
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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