FDAFDA · Food and drugs·Recall number Z-1148-2017
AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed polyethylene terephthalate glycol (PETG) tray with a Tyvek¿ lid. A single-walled non-corrugated box completes the single unit package. Six (6) single unit PRO2 devices are packaged into one (1) corrugate shipper box.
Published February 15, 2017 · Recall initiated: November 30, 2016
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
A complaint of the PRO2 jaw breaking prior to surgery being performed.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AtriCure, Inc.
- Distributor
- Devices were distributed in the following states: AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, NE, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, & WI. Devices were distributed in the following countries: Austria, Germany, Netherlands, Poland, Sweden, Switzerland and United Kingdom.
- Lot
- Model Numbers: PRO235, PRO240, PRO245, PRO250 Lot Numbers: 67102 to 68418
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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