The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Reason for recall: The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). Distribution: U.S.: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV O.U.S.: Brazil Quantity: 1,325 systems Lot/code info: List Number: 03R65-01 Serial Numbers / UDI-DI codes (for U.S. systems only): AI01413 (01)00380740137366(21)AI01413 AI01414 (01)00380740137366(21)AI01414 AI01434 (01)00380740137366(21)AI01434 AI01447 (01)00380740137366(21)AI01447 AI01467 (01)00380740137366(21)AI01467 AI01468 (01)00380740137366(21)AI01468 AI01599 (01)00380740137366(21)AI01599 AI01607 (01)00380740137366(21)AI01607 AI01796 (01)00380740137366(21)AI01796 AI01823 (01)00380740137366(21)AI01823 AI01824 (01)00380740137366(21)AI01824 AI01827 (01)00380740137366(21)AI01827 AI01830 (01)00380740137366(21)AI01830 AI01837 (01)00380740137366(21)AI01837 AI01839 (01)00380740137366(21)AI01839 AI01873 (01)00380740137366(21)AI01873 AI01874 (01)00380740137366(21)AI01874 AI01991 (01)00380740137366(21)AI01991 AI02055 (01)00380740137366(21)AI02055 AI02056 (01)00380740137366(21)AI02056 AI02057 (01)00380740137366(21)AI02057 AI02058 (01)00380740137366(21)AI02058 AI02109 (01)00380740137366(21)AI02109 AI02110 (01)00380740137366(21)AI02110 AI02111 (01)00380740137366(21)AI02111 AI02117 (01)00380740137366(21)AI02117 AI02199 (01)00380740137366(21)AI02199 AI02201 (01)00380740137366(21)AI02201 AI02208 (01)00380740137366(21)AI02208 AI02232 (01)00380740137366(21)AI02232 AI02234 (01)00380740137366(21)AI02234 AI02288 (01)00380740137366(21)AI02288 AI02292 (01)00380740137366(21)AI02292 AI02293 (01)00380740137366(21)AI02293 AI02345 (01)00380740137366(21)AI02345 AI02368 (01)00380740137366(21)AI02368 AI02391 (01)00380740137366(21)AI02391 AI02392 (01)00380
00380740137366
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.