Device Recall Presource Custom Sterile Convenience Packs/Modules

  • Model / Serial
    Lube Jelly, 1 oz. tube, component catalog #8884430200, packaged in teh following Presource Custom Sterile Convenience Packs/Modules: Cat #MBA33BULFF, lots 13636 and lot 8859; Cat #MMA33SCLFD, lot 17666; Cat #PB45LVPHS, lot 637365; Cat #PB95GYWMH, lot 639756; Cat #PB95LSWM3, lot 16532; Cat #PB95VHWMK, lot 648972; Cat #PBCGOTCD2, lot 987883; Cat #PC42OHNK1, lot 985687; Cat #PCVACV60I, lot 16685; Cat #PCVMOHB66C, lot 991632; Cat #PGVMLPBJ3, lot 986923; Cat #PL23LICVJ, lot 643894; Cat #POVFMJAGP, lot 10304554; Cat #PPV2CYWCF, lot 10305683; Cat #PU24CCJMT, lots 12027 and 16562; Cat #PU42CCTMC, lot 641817; Cat #PU42RPHCE, lot 640532; Cat #PU60PYMME, lot 16237; Cat #PUOCUSRCL, lot 10305701; Cat #PUVMCCCHJ, lots 989215 and 991685; Cat #PUVMGMCHL, lot 990250; Cat #PUVMPYBJZ, lot 989986; Cat #PV35OTSTA, lot 987931; Cat #PV35OTSTB, lots 992803 and 993264; Cat #SBA11CSMMB, lot 13601; Cat #SBA11CYHHC, lot 8474; Cat #SBA11CYOHG, lots 10651 and 16902; Cat #SBA11CYRHH, lot 14693; Cat #SBA11CYSBM, lot 10653; Cat #SBA11LESLB, lots 12037 and 16998; Cat #SBA11TUPDA, lot 11855; Cat #SBA12CYGTV, lot 636910; Cat #SBA12CYNMD, lot 16179; Cat #SBA12CYYHJ, lot 13614; Cat #SBA12MCROO, lot 10654; Cat #SBA13CCCOH, lot 17013; Cat #SBA13CTAMA, lot 14088; Cat #SBA13CYBSN, lot 14578; Cat #SBA13CYDHG, lot 18714; Cat #SBA13CYMEC, lot 15279; Cat #SBA13CYRWG, lot 15251; Cat #SBA14CYMSM, lot 635654; Cat #SBA18COFHD, lot 15253; Cat #SBA18PRSFM, lot 15424; Cat #SBA22CYBAL, lot 13619; Cat #SBA23BOUCF, lots 13954 and 17184; Cat #SBA23CPWMC, lot 13960; Cat #SBA23CTMRE, lot 637026; Cat #SBA23CYDH1, lot 13970; Cat #SBA23CYDH2, lot 17196; Cat #SBA23CYNCF, lot 13977; Cat #SBA23ENPAF, lot 12584; Cat #SBA23RPVDB, lot 16676; Cat #SBA23RUDUG, lot 14426; Cat #SBA24CYNOA, lot 13822; Cat #SBA26CYSUH, lot 13983; Cat #SBA29TRSHE, lot 991913; Cat #SBA31CYMDD, lot 989212; Cat #SBA33CYDWI, lot 636144; Cat #SBA33CYVAA, lot 992691; Cat #SBA35CYBHH, lots 988344 and 991920; Cat #SBA35CYSTF, lots 987967 and 992681; Cat #SBA35GPBPD, lots 989696 and 991674; Cat #SBA35GUMOI, lots 988577 and 991956; Cat #SBA35MUSFF, lot 993256; Cat #SBA35STBLH, lot 988354; Cat #SBA35TPPHG, lots 988560 and 989317; Cat #SBA35TRVSA, lots 990857 and 986052; Cat #SBA35URBLK, lot 989223; Cat #SBA36CYAGI, lot 640323; Cat #SBA36CYRHB, lot 636791; Cat #SBA3DCPMME, lot 16681; Cat #SBA41CYWRC, lot 642143; Cat #SBA42CSVCJ, lot 641799; Cat #SBA45CYVHG, lot 987963; Cat #SBA48CYMHF, lot 990038; Cat #SBA53CYPHC, lot 651069; Cat #SBA69CYFSF, lot 643156; Cat #SBA7ACTPNB, lot 12331; Cat #SBAHDCYRVB, lot 13817; Cat #SBAHDRBRVC, lot 14289; Cat #SBAHDTUMJD, lot 13180; Cat #SBAHFTUMDA, lot 12040; Cat #SBAOCCYWHD, lot 14587; Cat #SID11SPSBC, lot 13358; Cat #SLC23RPUCI, lot 15379; Cat #SLC69VLWSB, lot 988883; Cat #SLC81RPBGD, lot 642484; Cat #SMA11CYPCF, lot 14046; Cat #SMA11DCNYO, lot 15311; Cat #SMA11LASBL, lot 12994; Cat #SMA11VGMME, lots 12032 and 16808; Cat #SMA12CPMWP, lot 642441; Cat #SMA12CYAIF, lots 17199 and 8791; Cat #SMA12HSROM, lot 8792; Cat #SMA12TIKGH, lot 15315; Cat #SMA12VHROI, lot 641006; Cat #SMA13BCNAE, lot 17560; Cat #SMA13DCWOE, lots 12816 and 17237; Cat #SMA14VGOGI, lot 640749; Cat #SMA18CASFE, lot 643785; Cat #SMA23DCALB, lot 11728; Cat #SMA23LVMRK, lot 15653; Cat #SMA23TUMRK, lot 16940; Cat #SMA23VAMRR, lot 634328; Cat #SMA40DCBYA, lot 10383; Cat #SMA81HYNME, lot 641022; Cat #SOT41CPHNE, lot 16371; Cat #SOT48RPSEA, lot 643755; Cat #SRHHFGMMMB, lot 12734; Cat #SRHHFGMMMC, lot 18570; Cat #SRHHFNYMMD, lot 17275; Cat #SRHHFOCMMB, lot 12683; Cat #SRHHFTBMMC, lot 12719; Cat #SRICY0567H, lot 640058; Cat #SRICY0695M, lot 10436; Cat #SRICY0736T, lot 14801; Cat #SRIGS1342L, lots 11012, 14264 and 18467; Cat #SUT81CPBGF, lot 641445;
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Lube Jelly, 1 oz. water-base sterile lubricating jelly, a component of various Presource Custom Sterile Convenience Packs/Modules; Packaged by Cardinal Health Medical Products and Services, McGaw Park, IL 60085 U.S.A.; The affected lots of modules actually contain a 1 oz. tube of Non-Sterile Kendall Vaseline White Petroleum Jelly. || Designed to assist hospitals in preparing for procedures by grouping all of the necessary components used for a procedure in one wrapper.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Cardinal Health, 1430 Waukegan Rd, Mc Gaw Park IL 60085-6726
  • Manufacturer Parent Company (2017)
  • Source
    USFDA