Devices

Presource Custom Sterile Surgical and Procedure Kits

  • Model / Serial
    all recent lot numbers of the following kit catalog numbers 03-0271, 03-0692A, 03-4563C, 05-0102, 09-5197F, 12-0088, 12-5210U, 12-5596, 13-0426E, 13-0879, 13-1527B, 17-2701B, 23626-640, 23626-660, 24012-060, 24012-360, 5C4150A, CFISP3EDTA, CFISPDHCBA, CS9044 and CS9046
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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 for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C; Act: || a) Split Dressing - 2"x 2", Yellow, component C-033-0022, vendor part number S1072; || b) Tubing Extension Sets and IV Sets || component C-FG711297CP, vendor pn FG711297CP; || component C-FG711093CP, vendor pn FG711093CP; || component C-FG711298CP, vendor pn FG711298CP; || component C-FG711092CP, vendor pn FG711092CP; || c) Cast Padding || component C-9046, vendor pn 9046; || component C-9044, vendor pn 9044; || component C-9043, vendor pn 9043; || component C-9062, vendor pn 9062; || d) Scalpel Holder || component C-DD1628-6, vendor pn DD1628-6; || e) Latex Tubing || component C-806-12, vendor pn 806-12; || component C-808R, vendor pn 808R; || component C-606R, vendor pn 606R; || component C-122BA10, vendor pn 122BA10; || component C-122BA12, vendor pn 122BA12; || component C-122BA07, vendor pn 122BA07; || component C-102BA12, vendor pn 102BA12; || component C-099BA10, vendor pn 099BA10; || component C-102BA10, vendor pn 102BA10; || component C-103BA10, vendor pn 103BA10; || component C-124BA10, vendor pn 124BA10; || component C-140BA10, vendor pn 140BA10; || f) Clinic Dropper || component C-12548, vendor pn 10-871-00; || g) Tongue Blade (depressor) || component C-11820-010, vendor pn 07-920-00; || h) Catheter Clamp || component C-043-0497, vendor pn 033403-887; || i) Gillette Good News Razor || component C-P4417A, vendor pn 4417GN; || j) Prepsicle Round Short Blue Swabstick || component C-051-0401, vendor pn SBR20035; || k) Tubing || component C-SFM3-3050, vendor pn SFM3-3050; || component C-SFM3-3650, vendor pn SFM3-3650; || l) Specimen Container || component C-B9021YN, vendor pn B9021YN; || component C-C8846-18, vendor pn 15706-806; || 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.
  • Manufacturer
    Cardinal Health
  • 1 Event

Manufacturer

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

8 devices with a similar name

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Presource Custom Sterile Surgical and Procedure Kits
  • Model / Serial
    all recent lots of the following kit catalog numbers PB53VDOCF, PB54ADSNO, PBCGCSEZC, PBCGDKEZC, PBHFVDLRG, PBVBSCNMK, PC21OHHOF, PC43CCLGC, PC43OH79D, PECGCL16M, PECGET16D, PEOCMEBL1, PEOCMEBLD, PEVTCESWV, PG69VSUS1, PG69VSUSF, PGCGOTUI8, PH76OTMDS, PH76TCMDR, PL23CSAML, PL23VDMPY, PL29OTRMU, PL41CSHSO, PL41VD16I, PL41VD87F, PL42VGTMG, PL42VGTMH, PL42VGTMI, PL54OTSMG, PL57DVSCI, PL57SCSCG, PL73CSSJU, PL73FBDWC, PL81CS99M, PL81VDSFX, PL8FCSSVA,  PL8FVDSVB, PLCGLR52A, PLCGOTMJU, PLCGVD66B,  PLCNCSHSW, PLCNLRLVU, PLVBCSSFR, PLVQMBPAD,  PN46CRKMA, PN48NNCHB, PNCGSPCDR, PNOCCRBLF,  PNVMCFBHG, PNVMCRBHM, PP15ICFCK, PPOCLGBSN,  PU40TRSOJ, PUOCOTSO1, PW82BSTCQ, PZ15LRFCC,  PZ51BCA701, PZ51BCA70C, PZMHADFBH, PZMHNAKYG,  PZOCADBSD, PZOCADFRB, PZOCBCGVD, PZVBOTANMS,  PZVZOTMIE, SAM55AMQMC, SAN12MPWCD, SAN21MYHOD,  SAN23AGDHC, SAN23ANDHF, SAN26BTACB, SAN31PPELF,  SAN48CCCHP, SANHDMRUMA, SANHDPRPIA, SBA13BNMGC, SBA13BNMGD, SBA18LCSCJ, SBA24BBMMA, SBA33PMSMA, SBA33PMSMB, SBA44IRMDC, SBA4APEJHE, SBB32BBNMD, SBB32BBNME, SBB53BTEVD,  SBB55BBMMG, SCV19OHCH6, SCV22AOKMA, SCV43CVBRI,  SCV43OHMWQ, SCV44NUHWA, SCV51VCKKD, SCVHBHSTMC, SEN13ORBWK, SEN19BSFMF, SEN31NSLUQ, SEN31PPLUK, SEN31PPNMA, SEN31TALUP, SEN31THLUR, SEN51HDKKD, SEN5CEPGSC, SID51STKKA, SMA32EAHSA, SMA33EACBC, SNE11PMDO2, SNE11PMDOB, SNE12EPNEA, SNE19CRCHU, SNE32CPSV1, SNE32CPSVC, SNE32CPSVE, SNE32CPSVF, SNE35LFBHB, SNE35LMBHI, SNE36STWPH, SNE48LPWLC, SNE51LMKKG, SNU23BSCHF, SNU42BSNKC, SOP21BSDKC, SRI63ACUMC, SRIGS0049M, SRINU0546N, SRINU0546O, SRINU0866J, SRIOR0870H, SRIOR0870I, SRIOR0871K, SRIOR0871L, UMA24CE43T, UMA24VA439 and UMA24VA43S
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including California, Florida, Illinois, Kentucky, Minnesota, Missouri, Ohio, Tennessee, Washington, West Virginia and Wisconsin
  • Product Description
    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 for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C; Act: || a) 24" Infant Tape Measure, component 30942P; || b) Silicone Tubing, component SFM3-4450; || c) Triple Dye Drug, 10 unit dose, component PM1022; || d) Assembly Swabstick, component PS004; || e) 18x26 Poly Lined Towel, component 8580Z; || f) Disposable Vein Stripper, component 63-0431; || g) Cotton Glove, Large, White, PR, NS, component 1051; || h) Cotton Glove, Medium, White, PR, NS, component 1051M; || i) 6 Inch Metric-Inch Ruler, component 18C-Thru; || 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.
  • Manufacturer
    Cardinal Health
Presource Custom Sterile Surgical and Procedure Kits
  • Model / Serial
    all recent lots of the following kit catalog numbers 03-2503F 03-2503H, 03B5615C, 4628, BA3CG4740K, BAB239109A, BAB920079C, MA1567670P, MA2CG6972D, MAN21ATAMC, MAT453740O and MATW11527D
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including California, Florida, Illinois, Kentucky, Minnesota, Missouri, Ohio, Tennessee, Washington, West Virginia and Wisconsin
  • Product Description
    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 for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C; Act: || a) Adhesive Remover Wipes, component 050-0415; || b) Perineze Perineal Witch Hazel Pad, component 505040A || c) 24" Infant Tape Measure, component 30942P; || d) Triple Dye Drug, 10 unit dose, component PM1022; || 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.
  • Manufacturer
    Cardinal Health
Device Recall Presource Custom Sterile Surgical and Procedure Kits
  • Model / Serial
    all recent lots of the following kit catalog numbers PBVFLCAVJ, PCW1VPMUW, PE41TP55A, PE73EALUO, PE73MNLUM, PEDKEASTH, PEOCMEBL1, PEOCMEBLD, PEVFBHAVK, PEVFENAVH, PEVFHNAVJ, PEVNMJCHF, PG73HNLUL, PG73OTALUN, PGCGOTUI8, PGCGOTUII, PGVFGMAVM, PGVFLPAVC, PGVFMNAVG, PGVFOTAVD, PGVFTTAVK, PGVNGSCHJ, PLVFOTAVJ, PN21CYBIG, PN21CYBIH, PN41CY557, PN73CR11F, PN73SPLUT, PN73VPLUV, PNV2ALCPA, PNV2CY10Z, PNV2LM10R, PNV2OT10H, PNV2OTA10Q, PNVFLNAVK, PO73AALU1, PO73AALUR, PP69OHMLO, PUOCOT13J, PVV2CA10B, SBA13KDBSY, SBA23KTNCC, SBA23OPNCC, SBACGSTAHA, SCV11CACPR, SCV19OHCHX, SCV23MJNCH, SEN41TYCMC, SID21ACUHA, SIDCGISAUA, SNE11ALCPA, SNE11CR10F, SNE11LM10C, SNE11NMCPX, SNE14ACHHK, SNE14CRHHK, SNE14LLHHN, SNE21SHEGS, and SNE32CRSA7.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- California, Georgia, Illinois, Massachusetts, Michigan, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin.
  • Product Description
    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) Silastic Tubing, 0.062 ID x 0.032 Wall x 50 Ft, component C-602-285, vendor part number SFM3-2850; || b) Silastic Tubing, 0.040 ID x 0.023 Wall x 50 Ft, component C-SFM3-2050, vendor part number SFM3-2050; || c) Pathology Container with Lid, 8 oz., component 3701Z, vendor part number 3701; || d) Silicone Tubing, 0.187 ID x 0.313 OD x 50 Ft., component C-31010SG, vendor part number 31010;
  • Manufacturer
    Cardinal Health
Device Recall Presource Custom Sterile Surgical and Procedure Kits
  • Model / Serial
    all recent lots of the following kit catalog numbers ICU955327G, ICU955327H, and MAT330041C.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- California, Georgia, Illinois, Massachusetts, Michigan, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin.
  • Product Description
    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;
  • Manufacturer
    Cardinal Health
Device Recall Presource Custom Sterile Surgical and Procedure Kits
  • Model / Serial
    all recent lots of the following kit catalog numbers SBA48UMCHF, SMA21CIDCB, SMA21CRDCC, SMA21CRDCD, SRHHFCIMM1, SRHHFCIMM2, SRHHFCIMMA and SRHHFCIMMB
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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.
  • Manufacturer
    Cardinal Health
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