Convenience kits containing select SKUs of Polycarbonate recalled

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

DYNJ905153J UDI-DI 10193489395464 Lots 21HBD986 21HBO570 21JBK103 21LBC610 22BBV026 22CME902 22GMG562 DYNJ905153K UDI-DI 10195327187866 Lots 22IMF393 22JMG893 23AMG164 23BMB570 DYNJ905153L UDI-DI 10195327405519 Lots 23FME792 23GMD683 23JMF608 23JMG151 DYNJ49593A UDI-DI 10889942275700 Lot 21FBM893 DYNJ46550K UDI-DI 10195327466992 Lot 24CMB215 DYNJ905157G UDI-DI 10193489397420 Lots 21BBG946 21DBD729 21EBO606 21HBN881 21IBE897 21KBA400 21KBO309 21LBC591 21LBG289 22CBV171 22DMI216 22EMH096 22FMC402 22GMG222 22OBE713 DYNJ905157I UDI-DI 10195327219925 Lots 22LMA455 22LMG933 DYNJ905157J UDI-DI 10195327406004 Lots 23GMB987 23IMA700 DYNJ56930B UDI-DI 10193489631289 Lot 24BBD644 DYNJ905160J UDI-DI 10193489908954 Lots 21GBT443 21HBN882 21JBA979 21KBA397 21KBA398 21LBH668 22CBV042 22DMI217 22EMB282 22EME050 22GMG599 22NBB158 DYNJ905160K UDI-DI 10195327187965 Lots 22IMF392 22JME891 22LME862 23AMB124 23AMB378 23AMC123 23BMB201 23BMF724 DYNJ905160M UDI-DI 10195327556723 Lots 23KMD689 23LMC509 24BMA402 DYNJ0843063K UDI-DI 10195327286460 Lots 23ADB394 23BDA963 23CDC020 23EDA191 23FDB421 23HDC666 23JDA179 23LDA280 DYNJ80196 UDI-DI 10195327014469 Lot 25CBK877 DYNJ908706 UDI-DI 10195327154585 Lots 22HMG258 23AMC139 23AME093 23AMH476 23BMF735 DYNJ908706B UDI-DI 10195327556907 Lots 23LMC084 24AMC273 24BMJ061 24CMC665

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.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.