Events

Recall of Device Recall Safety PICC Insertion Tray with Chloraprep OneStep

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Custom Healthcare Systems, Inc..

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
    69762
  • Event Risk Class
    Class 2
  • Event Number
    Z-2096-2015
  • Event Initiated Date
    2014-11-05
  • Event Date Posted
    2015-07-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132569
  • 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
    Needle, catheter - Product Code GCB
  • Reason
    An incorrect item number is packed within the outside "piggybacked" package. the interior sealed sterile kit is correct and no adverse issues affect that part of the item. the non-sterile outside "piggybacked" package mistakenly contains item #8881579121 - syringe prefilled, saline flush, 09% sodium chloride and is a nonsterile product that cannot be dropped into the sterile field.
  • Action
    Custom Healthcare System sent an Urgent Product Recall letter dated November 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. PLEASE CHECK YOUR INVENTORY AND QUARANTINE ANY AFFECTED PRODUCT MATCHING THE DESCRIPTIONS ABOVE. Call 804 (421-5959) with regards to returning the affected products. Return Authorizations will be issued and product pickup and return will be scheduled.

Device

Device Recall Safety PICC Insertion Tray with Chloraprep OneStep
  • Model / Serial
    Lot#92414 Exp Date 11/1/15, Lot#100214 Exp Date 11/1/15 Lot#100914 Exp Date 11/1/15
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to CT.
  • Product Description
    Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
  • Manufacturer
    Custom Healthcare Systems, Inc.

Manufacturer

Custom Healthcare Systems, Inc.
  • Manufacturer Address
    Custom Healthcare Systems, Inc., 4205 Eubank Rd, Richmond VA 23231-4328
  • Manufacturer Parent Company (2017)
    Custom Healthcare Systems Inc.
  • Source
    USFDA