FDAClass IIJune 3, 2020

Clip Applier Kit recall

Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)

Why was Clip Applier Kit 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: 1380797, 1382197

Product
Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)
Recalling firm
Applied Medical Resources Corp
Quantity
12 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)
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