Potential that the induction seal is not completely sealed to the device tube packaging.
Reason for recall: Potential that the induction seal is not completely sealed to the device tube packaging. 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, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and WY and the Virgin Islands and the country of Malaysia. Quantity: 12,166 units Lot/code info: Model/Catalog Number: 31815; UDI #: 10381780486886; Lot #s: 2328, 2332 and 2333;
10381780486886
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.