Cardinal Health: 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.

Recall number

Z-1104-2012

Recalling firm

Cardinal Health

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.

Status

Terminated

Initiated

2012-01-27

Posted

2012-02-24

Terminated

2016-08-01

Reason

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.

Root cause

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

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.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

LRO

Firm FEI

3001236905

Firm city

Park

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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