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
    59909
  • Event Risk Class
    Class 2
  • Event Number
    Z-0141-2012
  • Event Initiated Date
    2011-09-03
  • Event Date Posted
    2011-10-31
  • 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=103975
  • 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
    Tray, surgical - Product Code LRP
  • 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 September 2, 2011 to all affected 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 in their inventory. The labels have an ID code which coincides with the code on the component attachment to the letter. If the consignee does not wish to accept overlabeled product or to overlabel the product in their possession, they were asked to contact Presource Sales Operations at 800-766-0706 or their Sales Representative for further instructions. 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 the following: Hospitals - Presource Sales Operations at 800-766-0706, Distributors - Distributor Management Group at 800-635-6021, and Federal Government facilities - Government Service at 800-444-1186. For questions regarding this recall call 847-887-6412.

Device

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

Manufacturer

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