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: 1,127 systems Lot/code info: List Number: 03R67-01 Serial Numbers / UDI-DI codes (U.S. systems): AC01225 (01)00380740137380(21)AC01225 AC01226 (01)00380740137380(21)AC01226 AC01256 (01)00380740137380(21)AC01256 AC01257 (01)00380740137380(21)AC01257 AC01263 (01)00380740137380(21)AC01263 AC01264 (01)00380740137380(21)AC01264 AC01273 (01)00380740137380(21)AC01273 AC01274 (01)00380740137380(21)AC01274 AC01275 (01)00380740137380(21)AC01275 AC01356 (01)00380740137380(21)AC01356 AC01357 (01)00380740137380(21)AC01357 AC01358 (01)00380740137380(21)AC01358 AC01503 (01)00380740137380(21)AC01503 AC01504 (01)00380740137380(21)AC01504 AC01505 (01)00380740137380(21)AC01505 AC01506 (01)00380740137380(21)AC01506 AC01507 (01)00380740137380(21)AC01507 AC01508 (01)00380740137380(21)AC01508 AC01509 (01)00380740137380(21)AC01509 AC01510 (01)00380740137380(21)AC01510 AC01512 (01)00380740137380(21)AC01512 AC01513 (01)00380740137380(21)AC01513 AC01518 (01)00380740137380(21)AC01518 AC01521 (01)00380740137380(21)AC01521 AC01522 (01)00380740137380(21)AC01522 AC01523 (01)00380740137380(21)AC01523 AC01553 (01)00380740137380(21)AC01553 AC01554 (01)00380740137380(21)AC01554 AC01561 (01)00380740137380(21)AC01561 AC01566 (01)00380740137380(21)AC01566 AC01582 (01)00380740137380(21)AC01582 AC01584 (01)00380740137380(21)AC01584 AC01585 (01)00380740137380(21)AC01585 AC01588 (01)00380740137380(21)AC01588 AC01589 (01)00380740137380(21)AC01589 AC01591 (01)00380740137380(21)AC01591 AC01593 (01)00380740137380(21)AC01593 AC01594 (01)00380740137380
00380740137380
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.