Medline Industries, LP recalls Convenience kits containing select SKUs of 10mL Polycarbonat

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: DYNJ905291B UDI-DI 10193489950373 Lots 21GBO405 21JBX734 21LBO216 DYNJ905291C UDI-DI 10195327062545 Lots 22BBB434 22CBT553 22CBT556 22FBE950 22GBZ363 22LBQ583 23ABE635 23CBI463 DYNJ28082G UDI-DI 10195327050559 Lots 22BBL073 22DBT712 22FBU975 22IBD336 22LBH042 23BBG319 23CBW711 23EBF014 DYKM2130A UDI-DI 10195327630904 Lot 24ELA817 DYNJ0678934J UDI-DI 10195327637378 Lot 24FMI941 DYNJ23456J UDI-DI 10193489449839 Lot 21BMB927 DYNJ0842873K UDI-DI 10195327286613 Lots 22KDB463 23ADA210 23CDA339 23CDB773 23EDB190 23FDB457 23HDA476 23IDC327 23JDB182 23JDC057 24ADB081 24BDB286 24CDB934 24GDA042 24HDA590 24HDC238 DYNJ65925B UDI-DI 10193489925326 Lots 21FLA630 21GLA415 21HLA270 21JLA166 21KLA318 22CLA057 22CLA817 22DLA206 22ELA964 DYNJ65925C UDI-DI 10195327201371 Lots 23CLB075 23ELA853 23HLA442 23ILA022 DYNJ68037 UDI-DI 10193489473889 Lots 21ABT991 21HBL486 DYNJ901681D UDI-DI 10193489308099 Lot 24EMH538 DYNJ51853C UDI-DI 10193489269000 Lots 21CBB992 21DBA936 21FBE790 21HBN274 21KBA699 21KBP057 DYNJ51853D UDI-DI 10195327101336 Lots 22EBB104 22HBF054 22IBE507 22JBJ069 22KBS971 22LBT245 22NBG258 22OBI766 23ABI851 DYNJ60606A UDI-DI 10193489693386 Lot 24BBA469 DYNJ40952A UDI-DI 10193489941906 Lots 21GBR992 21JBX464 22BBS266 22CBP195 22EBS044 DYNJVB1303A UDI-DI 10193489928358 Lots 23ELB088 23FLA355 DYNJ0780143K UDI-DI 10195327477240 Lot 24AMI797 DYNJ0101291D UDI-DI 10193489381931 Lots 21CDC066 21EDB518 21GDC932 21HDC814 22BDA495 22DDB731 22DDC457 22EDB642 22GDA964 22JDA001 22JDC181 DYNJ69172 UDI-DI 10193489899603 Lots 21GMA692 21IMH791 DYNJ69172B UDI-DI 10195327487027 Lot 23KMC637 DYNJ57543F UDI-DI 10195327279028 Lot 23AMF931 DYNJ57543I UDI-DI 10195327359362 Lot 23CMD266 DYNJ57543J UDI-DI 10195327416027 Lots 23GMD945 23GMG266 DYNJ61702A UDI-DI 10193489470321 Lots 21CBN901 21FBM858 21GBE705