FDA-Device2018-07-25Class II
PRONOVA SUTURE BLUE 122CM M1.5, D10189
Ethicon, Inc.
Hazard
The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
Sold states
Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.
Affected count
516
Manufactured in
Us Highway 22 West, Somerville, NJ, United States
Products
PRONOVA SUTURE BLUE 122CM M1.5, D10189
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2466-2018Don't want to check this manually?
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