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U.S. Department of Health and Human Services

Class 2 Device Recall Presource Custom Sterile Convenience Packs/Modules

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  Class 2 Device Recall Presource Custom Sterile Convenience Packs/Modules see related information
Date Initiated by Firm February 28, 2011
Date Posted April 13, 2011
Recall Status1 Terminated 3 on April 19, 2012
Recall Number Z-1968-2011
Recall Event ID 58054
Product Classification Patient Lubricant - Product Code KMJ
Product 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.
Code Information 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; 
Recalling Firm/
Manufacturer		 Cardinal Health
1430 Waukegan Rd
Mc Gaw Park IL 60085-6726
For Additional Information Contact Michele B. Donatich R.N.
847-887-6412
Manufacturer Reason
for Recall		 The Presource kits were assembled with non-sterile petroleum base lubricant instead of the labeled sterile water base lubricating jelly.
FDA Determined
Cause 2		 Employee error
Action Cardinal Health issued an URGENT: PRODUCT RECALL letter dated February 28, 2011 to all affected consignees via UPS next day air, informing them that their Presource kit/modules listed in the attached spreadsheet contain a non-sterile petroleum-based lubricating jelly instead of the labeled water-based sterile lubricating jelly. Cardinal instructed the accounts to quarantine the pack/modules with the indicated work order/lot number on the enclosed spreadsheet and contact the appropriate Customer Service group listed in the letter for return instructions. The accounts were also requested to complete and fax back to Cardinal the enclosed reply sheet acknowledging receipt of the letter and the number of pack/modules being returned. If the product was further distributed, then those customers should also be notified.
Quantity in Commerce 4,236 modules
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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