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: 995 systems Lot/code info: List Number: 02P24-01 Serial Numbers / UDI Codes: C400911 (01)00380740003746(21)C400911 C402913 (01)00380740003746(21)C402913 C460004 (01)00380740003746(21)C460004 C460033 (01)00380740003746(21)C460033 C460055 (01)00380740003746(21)C460055 C460066 (01)00380740003746(21)C460066 C460082 (01)00380740003746(21)C460082 C460158 (01)00380740003746(21)C460158 C460200 (01)00380740003746(21)C460200 C460375 (01)00380740003746(21)C460375 C460385 (01)00380740003746(21)C460385 C460396 (01)00380740003746(21)C460396 C460397 (01)00380740003746(21)C460397 C460408 (01)00380740003746(21)C460408 C460410 (01)00380740003746(21)C460410 C460422 (01)00380740003746(21)C460422 C460435 (01)00380740003746(21)C460435 C460439 (01)00380740003746(21)C460439 C460523 (01)00380740003746(21)C460523 C460532 (01)00380740003746(21)C460532 C460588 (01)00380740003746(21)C460588 C460728 (01)00380740003746(21)C460728 C460767 (01)00380740003746(21)C460767 C460797 (01)00380740003746(21)C460797 C460798 (01)00380740003746(21)C460798 C460800 (01)00380740003746(21)C460800 C460826 (01)00380740003746(21)C460826 C460827 (01)00380740003746(21)C460827 C460830 (01)00380740003746(21)C460830 C460832 (01)00380740003746(21)C460832 C460833 (01)00380740003746(21)C460833 C460834 (01)00380740003746(21)C460834 C460846 (01)00380740003746(21)C460846 C460849 (01)00380740003746(21)C460849 C460857 (01)00380740003746(21)C460857 C460868 (01)00380740003746(21)C460868 C460875 (01)00380740003746(21)C460875 C460886 (01)00380740003746(21)C460886 C46092
00380740003746, 00380740081225, 00380740003753
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.