Packaging failures were identified which could lead to a breach in the sterile barrier.
Reason for recall: Packaging failures were identified which could lead to a breach in the sterile barrier. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia. Quantity: 4 units Lot/code info: Model/Catalog Number: 31738; UDI- 10381780486961; Lot # 53824;
10381780486961
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.