Events

Recall of Spacelabs Healthcare HookUp kits

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Del Mar Reynolds Medical, Ltd..

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
    60205
  • Event Risk Class
    Class 2
  • Event Number
    Z-0262-2012
  • Event Initiated Date
    2011-10-12
  • Event Date Posted
    2011-11-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104739
  • 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
    Degreaser, skin, surgical - Product Code KOY
  • Reason
    The non-sterile alcohol prep pads (b339) are included in spacelabs healthcare hook-up kits may have the presence of a bacterium, bacillus cereus. these alcohol prep pads were manufactured and recalled by professional disposables international (pdi).
  • Action
    SpaceLabs Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated October 21, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop using the affected product and dispose of them per their hospital or clinic protocol. For questions contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.

Device

Spacelabs Healthcare HookUp kits
  • Model / Serial
    B339 is listed on the PDI Alcohol Prep Pads.  Hook-up kits that contain the affected alcohol prep pads are as follows:  Aria, Kit Part number 23189-010, Kit, Basic hookup, AA; CardioCall, Kit Part number 23189-020, Kit, Hookup, CardioCall; Aria, Kit Part number 23189-106, Kit, Aria Hookup; Aria, Kit Part number 23189-110, Kit, Aria Hookup; Flashcorder, Kit Part number 23189-111, Kit, Flashcorder Hookup; Aria, Kit Part number 23189-113, Holter Hookup Kit 7 electrode; LifeCard 12, Kit Part number 23189-114, Kit, Hookup, LC12, Multilingual; Aria, Kit Part number 23189-115, Kit, Basic Hookup, AAA; LifeCard, Kit Part number 23189-116, Kit, Holter Hookup, LifeCard; 483, Kit Part number 23189-117, Kit, Holter Hookup 483; Aria, Kit Part number 23189-153, Holter Hookup Kit, 7 electrode; Aria VLC, Kit Part number 23189-207, Kit, Aria Hookup, VLC; EVO, Kit Part number 50-0048, 4 electrode hookup kit without pouch; EVO, Kit Part number 50-0049, 4 electrode hookup kit with pouch; EVO, Kit Part number SK10456, Sample Kit, Disposables.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (natiowide) and the countries of South Africa, Turkey, Bangladesh, Dominican Republic, Peru, Belgium, Ecuador, Romania, Austria, Honduras, Guatemala, Denmark, Republic of Korea, Argentina, Thailand, Italy, Austria, Chile, Bolivia, Mexico, Sweden, Netherlands, Switzerland, India, Serbia, Australia, Morocco, Turkey, ISpain, Czech Republic, Slovakia, Poland, China, Columbia, Portugal, Canada, Germany, United Kingdom, Singapore, France, Russian Federation, Bahrain, and Kuwait
  • Product Description
    PDI Electrode Prep Pads, Skin Prep B339 are non-sterile alcohol prep pads. They are included in the Spacelabs Healthcare Hook-Up kits. Each kit contains 2-4 pieces of PDI Electrode Prep Pads . || Hook-up kits that contain the affected alcohol prep pads are as follows: || Aria, Kit Part number 23189-010, Kit, Basic hookup, AA; || CardioCall, Kit Part number 23189-020, Kit, Hookup, CardioCall; || Aria, Kit Part number 23189-106, Kit, Aria Hookup; || Aria, Kit Part number 23189-110, Kit, Aria Hookup; || Flashcorder, Kit Part number 23189-111, Kit, Flashcorder Hookup; || Aria, Kit Part number 23189-113, Holter Hookup Kit 7 electrode; || LifeCard 12, Kit Part number 23189-114, Kit, Hookup, LC12, Multilingual; || Aria, Kit Part number 23189-115, Kit, Basic Hookup, AAA; || LifeCard, Kit Part number 23189-116, Kit, Holter Hookup, LifeCard; || 483, Kit Part number 23189-117, Kit, Holter Hookup 483; || Aria, Kit Part number 23189-153, Holter Hookup Kit, 7 electrode; || Aria VLC, Kit Part number 23189-207, Kit, Aria Hookup, VLC; || EVO, Kit Part number 50-0048, 4 electrode hookup kit without pouch; || EVO, Kit Part number 50-0049, 4 electrode hookup kit with pouch; || EVO, Kit Part number SK10456, Sample Kit, Disposables. || A surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such as 1,1,2-trichloro-1,2,2-trifluoroethane; 1,1,1-trichloroethane; and 1,1,1-trichloroethane with mineral spirits intended to be used to dissolve surface skin oil or adhesive tape.
  • Manufacturer
    Del Mar Reynolds Medical, Ltd.

Manufacturer

Del Mar Reynolds Medical, Ltd.
  • Manufacturer Address
    Del Mar Reynolds Medical, Ltd., 1-2 Harforde Ct., Foxholes, Business Park, Hertford United Kingdom
  • Manufacturer Parent Company (2017)
    OSI Systems Inc
  • Source
    USFDA