FDAFDA · Food and drugs·Recall number Z-2158-2020
Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
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: 1364578/Expiration Date: July 28, 2022; Batch: 1366453/Expiration Date: August 13, 2022; Batch: 1371249/Expiration Date: October 3, 2022; Batch: 1373050/Expiration Date: October 23, 2022; Batch: 1373248/Expiration Date: November 4, 2022; Batch: 1373249/Expiration Date: November 11, 2022; Batch: 1373255/Expiration Date: November 18, 2022; Batch: 1373260/Expiration Date: November 19, 2022; Batch; 1373261/Expiration Date: November 24, 2022; Batch: 1373262/Expiration Date: December 2, 2022; Batch: 1373263/Expiration Date: December 5, 2022; Batch: 1377363/Expiration Date: December 11, 2022; Batch: 1377364/Expiration Date: December 17, 2022
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.