Epix latis GRASPER recall
Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154
Why was Epix latis GRASPER recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch: 1366454/ Expiration Date: August 25, 2022; Batch: 1371261/Expiration Date: October 7, 2022; Batch: 1371262/Expiration Date: October 14, 2022; Batch: 1373051/Expiration Date: October 29, 2022; Batch: 1373256/Expiration Date: December 1, 2022; Batch: 1376369/Expiration Date: December 10, 2022
- Product
- Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154
- Recalling firm
- Applied Medical Resources Corp
- Quantity
- 4320 units
- Distribution
- 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
- Recall date
- June 3, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)