Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Reason for recall: Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados. Quantity: 113,843 kits Lot/code info: DYNJ0854485S UDI-DI 10193489250558 Lot 21BMA604 DYNJ0842793G UDI-DI 10195327293666 Lots 22LDA183 23EDB049 23HDC042 23JDA988 24DDA005 DYNJ55385A UDI-DI 10193489762129 Lot 21ALA184 DYNJ51697B UDI-DI 10889942893652 Lots 21ABE325 21CBH476 21DBV407 21HBH690 21JBN408 21LBL194 21VBB105 22DBL109 22EBH117 22FBS410 22JBM660 22LBJ592 22NBG350 23BBR238 23CBH111 23DBN366 23GBE252 23HBP266 DYNJ56509G UDI-DI 10193489832082 Lots 21BBQ398 21BBR321 21CBO123 21DBM014 DYNJ56509I UDI-DI 10193489947113 Lots 21HBI572 21HBK163 DYNJ68063 UDI-DI 10193489872040 Lot 21FBN698 DYNJ68845 UDI-DI 10193489481006 Lot 21JBZ479 DYNJ68845A UDI-DI 10195327058104 Lot 22CBF908 22EBS916 DYNJ68845B UDI-DI 10195327211806 Lot 22HBL865 DYNJ0101287I UDI-DI 10193489434033 Lots 21CDA247 21EDA767 21GDC130 21HDA996 21KDA985 21LDA070 22BDA782 22CDC182 22EDB032 22GDA474 22IDB680 22KDB540 DYNJ0101287L UDI-DI 10195327567064 Lots 23LDB486 24BDB244 24FDA276 24FDB664 24HDC055 DYNJ82103 UDI-DI 10195327170998 Lots 22EMI175 22GMA639 DYNJ82103A UDI-DI 10195327260910 Lot 22KMH267 DYNJ67075 UDI-DI 10193489388473 Lot 21LLA292 DYNJ67075A UDI-DI 10195327054533 Lots 22CLB355 22DLA398 22ELA122 22ELA567 22FLA224 22HLA108 22HLB180 22ILB148 22KLA076 22LLA785 23ALA638 DYNJ67075B UDI-DI 10195327470852 Lots 23JLA177 23JLB271 23LLA274 24ALA492 24HLA695 24ILA933 24KLA029 24LLA559 25ALA880 DYNJ62960B UDI-DI 10193489911558 Lot 21HBD207 DYNJ0843121J UDI-DI 10193489444605 Lots 21ADB535 21CDC104 21FDC074 21HDB833 21HDC829 21LDA977 22ADB259 22BDB407 22EDB54
10193489250558, 10195327293666, 10193489762129, 10889942893652, 10193489832082, 10193489947113, 10193489872040, 10193489481006, 10195327058104, 10195327211806, 10193489434033, 10195327567064, 10195327170998, 10195327260910, 10193489388473, 10195327054533, 10195327470852, 10193489911558, 10193489444605, 10195327286491, 10193489234886, 10195327445072, 10193489925258, 10193489777550, 10193489567342, 10193489294071
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.