FDAFDA · Food and drugs·Recall number Z-1482-2022
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Published August 10, 2022 · Recall initiated: April 1, 2020
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aesculap Implant Systems LLC
- Distributor
- 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.
- Lot
- UDI-DI: 04046955083381, lots M45171; M46651; M47463; M48124; M49436.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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