Events

Recall of Device Recall 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
    60823
  • Event Risk Class
    Class 2
  • Event Number
    Z-0871-2012
  • Event Initiated Date
    2011-12-12
  • Event Date Posted
    2012-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106577
  • 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 manufacturer(s) does not have all necessary fda registrations or filings needed for this product.
  • Action
    Cardinal Health issued an URGENT: PRODUCT RECALL letter dated December 12, 2011 to the affected hospital consignees via UPS next day air. The letter informed them that their Presource kits listed in the attached spreadsheet contain various components also listed on the attachment that 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, instructing the user not to use the affected component upon opening the kit, to be affixed 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 Presource Sales Operations at 800-766-0706.

Device

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

Manufacturer

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