FDAClass IIAugust 10, 2022

Prestige Atraumatic Grasper W/port Dual Action recall

PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10

Why was Prestige Atraumatic Grasper W/port Dual Action recalled?

Endoscopic graspers may become separated at the weld from handle to the shaft of the device.

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?

UDI-DI: 04046955083374, lots M45041; M45399; M45711; M46069; M46350; M47462; M47893; M48115; M48279; M48346; M48467; M48596; M48753; M48848; M48907; M49375; M49435; M49632; M49683; M49711; M49867; M55796.

Product
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Recalling firm
Aesculap Implant Systems LLC
Quantity
3392
Distribution
United States Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Washington DC and Puerto Rico.
Recall date
August 10, 2022
Classification
Class II
Status
Completed
Agency
FDA (device)
Open FDA enforcement record Latest recalls