Device Recall Presource Custom Sterile Surgical and Procedure Kits

all recent lots of the following kit catalog numbers ICU955327G, ICU955327H, and MAT330041C.

General and Plastic Surgery Devices

1

No

Nationwide Distribution -- California, Georgia, Illinois, Massachusetts, Michigan, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin.

Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components: || a) Cool Peri-Pad Self-Adhesive Absorbent Pad with Built-In Cold Pack, component C-CP23, vendor part number CP23; || b) Giraffe Disposable Skin Temperature Probe, vendor part number 6600-0873-700;

all recent lots of the following kit catalog numbers SBA48UMCHF, SMA21CIDCB, SMA21CRDCC, SMA21CRDCD, SRHHFCIMM1, SRHHFCIMM2, SRHHFCIMMA and SRHHFCIMMB

General and Plastic Surgery Devices

2

No

Nationwide Distribution (USA) including the states of: Alabama, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Maryland, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Tennessee, Virginia, Washington and West Virginia.

Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL 60085; || The kit catalog numbers listed in the code information section below contain one or more of the following listed components: || a) Jobri Circumcision Strap, Small, 2 x 8 inch, component part number 086-0001; || b) Jobri Circumcision Strap, Large, 2 x 10 inch, component part number 086-0002; || The restraint is used to secure an infant during a circumcision procedure. || Product Usage: || 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 sterilized and are ready to be used by the customer for the specific procedure. The restraint is used to secure an infant during a circumcision procedure.

all recent lots of the following kit catalog numbers 02-0114C, 02-0336, 02-0619, 02-0790A, 02-1502B, 02-1880, 02-2064, 02-2843A, 02-3022A, 02-3867I, 02-3867J, 02-4716C, 02-7483, 02A0790A, 02B0790, 10-0023C, 10-0059A, 10-0078, 10-0079B, 10-0089, 10-1077B, 10-2637C, 10-3050C, NI10-0007B, NI10-0020H, NI10-0039, NI10-0073B, NI10-0083, NI10-5406, NI10-7799D, NI10-8184A and NI12-1714

General and Plastic Surgery Devices

2

No

Nationwide Distribution (USA) including the states of: Alabama, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Maryland, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Tennessee, Virginia, Washington and West Virginia.

Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McGaw Park, IL 60085; || The kit catalog numbers listed in the code information section below contain one or more of the following listed components: || a) Jobri Circumcision Strap, Small, 2 x 8 inch, component part number 086-0001; || b) Jobri Circumcision Strap, Large, 2 x 10 inch, component part number 086-0002; || The restraint is used to secure an infant during a circumcision procedure. || Product Usage: || 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 sterilized and are ready to be used by the customer for the specific procedure. The restraint is used to secure an infant during a circumcision procedure.

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

General and Plastic Surgery Devices

2

No

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.

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.