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U.S. Department of Health and Human Services

Class 2 Device Recall Presource Custom Sterile Surgical and Procedure Kits

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  Class 2 Device Recall Presource Custom Sterile Surgical and Procedure Kits see related information
Date Initiated by Firm January 27, 2012
Date Posted February 24, 2012
Recall Status1 Terminated 3 on August 01, 2016
Recall Number Z-1104-2012
Recall Event ID 61048
Product Classification General surgery tray (kit) - Product Code LRO
Product Presource Custom Sterile Surgical and Procedure Kits containing Ethicon Ethilon Black Nylon Nonabsorbable Surgical Sutures in new Tyvek packaging; surgical trays; Cardinal Health. The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then ethylene oxide sterilized and are ready to be used by the customer for the specific procedure.


The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then ethylene oxide sterilized and are ready to be used by the customer for the specific procedure.
Code Information all recent lots of the following kit catalog numbers PC23OHCTF, PC40OH80J, PC40OH811, PC44GCCMB, PCCGOHEZD, PCOCOHC11, PCOCOHCVT, PE63EMGHB, PE8ATHCSA, PG21OTSYB, PG22CRBRB, PGOCMJSFA, PGVMTOBL4, PGVMTOBL5, PGVMTOBLP, PGW1GSBLM, PGW1OBMUN, PHOCTHMTG, PJ35IVSBA, PN08CRGHA, PN13CRMGC, PNOCCY09I, PO08SAGH3, PO08SAGHM, PO15HATRB, PO41EXCAK, PO41KSCA3, PO41KSCAM, PO42KNTM5, PO42KNTME, PO42KNTMF, PO42SATM2, PO42SATMF, PO42SATMG, PO45ARSJV, PO45UASJMO, PO60ARLHW, PO60SHLHQ, POCGAAMJN, POCGAKJCB, POCGASJCA, PODKLVSTH, PODKPSSTH, POHBAAVAE, POOCARHTN, POOCARHTO, POOCSHEEM, POVMFABHE, POW1AKWMK, PU8ARLCSA, PVOCAAAWPK, PVV1OTGSN, SAN11PTLH1, SAN13INMTM, SAN19PIVAA, SAN19SBFMF, SAN23PLMU3, SAN23PLMU4, SAN23PLMUG, SAN23PLMUH, SAN23PLNCE, SAN30LHTGB, SAN34CIAVH, SAN34FSAVF, SAN44PITCO, SAN49PTMBF, SAN49PTMBG, SAN51INUCH, SAN56PIIHJ, SAN56RPIHG, SAN59DRTCG, SAN69SPWWI, SAN8FMAUAE, SAN8FMAUAF, SANCGPCAUB, SANCGPCAUC, SANW1CIHFA, SBA11TEWHF, SBA11THMME, SBA12LPHEB, SBA13BRLOG, SBA13RPBWD, SBA22BADRT, SBA23CTMUC, SBA23LBSGB, SBA34URMTE, SBA51CAEBG, SBA57UAOHG, SBA69CRSNB, SBA69HPCIK, SBA69PEWWI, SBA8FGRGMA, SBAOCBBASE, SCV11BORJP, SCV31PICMA, SCV33OHSM6, SCV73BHHGH, SCV7CVAGR1, SCV7CVAGRE, SEN41RNSUH, SER11LCCHD, SER11LCCHE, SLC12LPUVN, SNE11CANSN, SNE12CRKGA, SNE23SSRCL, SNE36CRWVL, SNE69VPWWF, SNU49CLM01, SNU49CLMBT, SOP11APIHD, SOP11ARHTI, SOP11ARJMP, SOP11ARNUK, SOP11ARPHI, SOP11ARWAC, SOP11RALHM, SOP11SHEEH, SOP11SHLHH, SOP11SHNUG, SOP13ARCYM, SOP13ARMSN, SOP13ARSHF, SOP13FFBI2, SOP13FTAKH, SOP13HAMEA, SOP13HNSFC, SOP13MAAKF, SOP13MOMHD, SOP13SAMSO, SOP13SHSFC, SOP14ARLM1, SOP14ARLMD, SOP18KNCOJ, SOP18SHCOH, SOP19ARMLK, SOP19KAVAI, SOP19UEMLF, SOP19UEMLG, SOP21KNSTD, SOP21SHSTC, SOP23ARRGC, SOP23SHCTB, SOP23SHCTC, SOP23SPCMB, SOP24ARJHA, SOP24HAOZA, SOP24KPOZB, SOP24SHJHA, SOP24SHOZB, SOP25ACCHF, SOP25ARVAF, SOP25SHCHG, SOP26HDSHF, SOP2RAROSB, SOP2RSPMB3, SOP2RSPMBD, SOP2RSPOSA, SOP31ARWSM, SOP32ARRVG, SOP32CTMCF, SOP32OHTRK, SOP33ARVDK, SOP33KADWI, SOP34HABSE, SOP34KAWSG, SOP35HNJWP, SOP35KAJWP, SOP35PHJWP, SOP35UXJWM, SOP36AKCOJ, SOP36KASUH, SOP40HAPSB, SOP40HPRVB, SOP41ARHGD, SOP41ARSMB, SOP41HNHMK, SOP41KSAGD, SOP41PASUI, SOP41SHAGD, SOP41SHHGB, SOP42BSSKL, SOP42KASKE, SOP42LHSKN, SOP42MCSKG, SOP42RHSKJ, SOP42SASKH, SOP42SHSLB, SOP42SMSKF, SOP42SSSKJ, SOP43KNSUB, SOP43RSMPA, SOP43SHMPB, SOP44ARBBI, SOP44SABBJ, SOP45ACCUE, SOP45ARUVA, SOP45KSCUF, SOP45SAHCB, SOP45SSCUD, SOP48ARHAI, SOP4BKACOF, SOP51HPBJE, SOP53CTOCC, SOP53SPBSD, SOP54ARDYG, SOP55ARWMJ, SOP61PDRHO, SOP63FHKHJ, SOP69CAFCG, SOP69CSFCE, SOP69KAOID, SOP69SHOID, SOP73ACCML, SOP73KACMB, SOPCGAHAUB, SOPCGAHAUC, SOPCGHNBJC, SOPCGKPBJC, SOPCGKPBJD, SOPCNHASDB, SOPHDARSMB, SOPOCHASAB, SOPOCKAASD, SOPOCKALIA, SOPW1SHBOG, SOT30RPVRF, SRH41HTTRB, SRI63LXULE, SRI63UXULF, SRIHT0861N and SRIOR0730S
Recalling Firm/
Manufacturer		 Cardinal Health
1430 Waukegan Rd
Mc Gaw Park IL 60085-6726
For Additional Information Contact Michele B. Donatich R.N.
847-473-1500
Manufacturer Reason
for Recall		 The Presource kits were assembled with Ethicon Sutures in new Tyvek packaging which could no longer be placed in kits that will undergo ethylene oxide sterilization.
FDA Determined
Cause 2		 Packaging change control
Action The firm, Cardinal Health, sent an "URGENT: PRODUCT RECALL" letter dated January 26, 2012 to the affected consignees via UPS next day air. The letter identified the product, problem, and actions to be taken. Enclosed with the letter were recall labels, instructing the customer not to use the affected sutures and to remove and destroy the sutures upon opening the kit, to affix recall label to the front side of each affected Presource kit and shipping carton currently in their inventory. The customers were also requested to complete and fax back to Cardinal at 847-689-9101 or 614-652-9648 regardless of whether or not you have inventory. For component credit/replacement the consignees were instructed to contact the following: Presource Sales Operations at 800-766-0706; Government Customer Service at 800-444-1166; and Distributor Management Group at 800-635-6021. For any questions, require additional labels or desire special assistance relating to this recall contact Cardinal Health Quality Systems, 800-292-9332.
Quantity in Commerce 18,300 kits
Distribution Worldwide distribution: USA (Nationwide) including the states of: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, West Virginia, Wisconsin and Washington; and country of Canada.
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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