Events

Recall of Presource Custom Sterile Surgical and Procedure Kits

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardinal Health.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60069
  • Event Risk Class
    Class 2
  • Event Number
    Z-0169-2012
  • Event Date Posted
    2011-11-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104377
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    General surgery tray (kit) - Product Code LRO
  • Reason
    Some of the components contained in the presource kits are being recalled because cardinal health has determined that the component manufacturers do not have all necessary fda registrations or filings needed for these components.
  • Action
    Cardinal Health issued an URGENT: PRODUCT RECALL letter dated September 30, 2011 to the affected wholesale consignees via UPS next day air, informing them that their Presource kits listed in the attached spreadsheet contain various components listed on the attachment, which are being recalled because the component manufacturer(s) do not have all the necessary FDA registrations or filings needed for these components. Enclosed with the letter were recall labels to affix to the front side of each affected Presource kit and shipping carton in their inventory. The labels have an ID code which coincides with the code on the component attachment to the letter. 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 labeled. For component credit, the consignees were instructed to contact Distributor Management Group at 800-635-6021. This wholesale recall was expanded to include additional kits via letter dated October 5, 2011, with the same instructions as listed above. For questions regarding this recall call 800-292-9332.

Device

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

Manufacturer

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