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: DYNJ905651B UDI-DI 10193489925067 Lot 24BME750 00-402001S UDI-DI 10889942893645 Lots 21ABV063 21BBK296 21OBA437 DYNJ0842516F UDI-DI 10193489352375 Lots 21BDB242 21CDC063 21HDB970 21IDB395 21KDC355 22BDA157 22DDB628 22FDA331 22GDB353 PHS463660F UDI-DI 10195327096991 Lots 22BBT652 22DBK236 DYNJ43580C UDI-DI 10889942249398 Lots 21BDB710 21DDB799 DYNDA2213A UDI-DI 10889942925421 Lots 23LBC294 DYNJ65277A UDI-DI 10193489409536 Lots 24BBD609 24BBD609A DYNJ0842793F UDI-DI 10193489345230 Lots 21CDA191 21CDC092 21EDA769 21GDB289 21HDC822 22BDB295 22DDA792 22EDB725 22IDC164 DYNJ67918 UDI-DI 10193489459081 Lots 21ABP630 21DBL459 21EBD905 21HBE280 21HBE285 21IBS959 21VBD188 DYNJ56666B UDI-DI 10888277740273 Lots 21BMB700 21CMA789 DYNJ44123A UDI-DI 10889942952977 Lots 21ABV982 21CBB916 21HBQ740 21KBE936 21VBC816 22ABS461 22CBX354 22DBD608 22EBT322 22GBR526 22HBS119 22LBA937 22LBM278 23ABJ758 23BBG292 23CBD680 DYNJ51126B UDI-DI 10195327044138 Lots 22ADA961 22BDC241 22DDA320 22DDB652 22FBD047 22FBH293 22HBQ223 22HBY535 22JBG518 PAIN1454 UDI-DI 10193489688863 Lots 21CBA985 21DBU969 21FBN495 21GBG636 21KBJ919 22ABJ583 22BBN243 22IBT753 22KBA570 23ABK226 23IBE552 23JBF419 23KBJ152 DYNJ905160I UDI-DI 10193489397482 Lots 21BBE987 21DBD058 21EBC916 DYNJ0843063J UDI-DI 10193489345377 Lots 21CDA233 21EDC220 21GDC682 21IDA570 21JDA064 21LDA151 22ADC136 22CDB166 22EDA616 22FDB836 22HDB150 22KDA481 DYNJ37304F UDI-DI 10889942727919 Lot 23KMI510 DYNJ56386B UDI-DI 10888277762886 Lots 21CBX170 21GBQ837 21JB
10193489925067, 10889942893645, 10193489352375, 10195327096991, 10889942249398, 10889942925421, 10193489409536, 10193489345230, 10193489459081, 10888277740273, 10889942952977, 10195327044138, 10193489688863, 10193489397482, 10193489345377, 10889942727919, 10888277762886, 10193489872002, 10884389898826, 10193489520279, 10889942777792, 10195327406042, 10193489472516, 10193489883596, 10193489569827
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.