FDAClass IIJune 3, 2020

Dr. Thames - LAP Chole recall

DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620

Why was Dr. Thames - LAP Chole 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: 1378830/Expiration Date: September 8, 2022; Batch: 1379253/Expiration Date: August 13, 2022; Batch: 1380094/Expiration Date: August 22, 2022; Batch: 1381695/Expiration Date: October 30, 2022

Product
DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620
Recalling firm
Applied Medical Resources Corp
Quantity
21 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)
Open FDA enforcement record Latest recalls