Events

Recall of Device Recall Evicel Accessory Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon, 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
    79668
  • Event Risk Class
    Class 2
  • Event Number
    Z-1534-2018
  • Event Initiated Date
    2018-03-07
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162948
  • 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
    Syringe, piston - Product Code FMF
  • Reason
    Products labeled for distribution outside the united states may have been distributed to customers in the united states.
  • Action
    Letters distributed on 3/7/18 to hospitals instructed them to: 1. Examine your inventory immediately to determine if you have the product lot subject to this recall (removal) on hand and quarantine such product(s). 2. Remove the product lot subject to this recall (removal) and communicate the issue to all relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any of the devices subject to this recall (removal) have been forwarded to another facility, please contact that facility to arrange return. 3. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax or email it to Stericycle at 1-877-473-7068 or Ethicon4528@stericycle.com within three (3) businessdays. Please return the BRF even if you do not have the product lot subject to this recall(removal). 4. Customers are required to return all unused EVICEL¿ 45 CM Flexible (Accessory) Tip devices for the lot subject to this recall (Lot 17-0102 Code EVT45) that are in their inventory immediately. Only unused EVICEL¿ 45 CM Flexible (Accessory) Tip devices for the lot subject to this recall (removal) returned by June 30, 2018 will be eligible for replacement. Any unused EVICEL¿ 45 CM Flexible (Accessory) Tip devices for the lot subject to this recall (removal) returned after June 30, 2018 will not be eligible for replacement. 5. To return unused EVICEL¿ 45 CM Flexible (Accessory) Tip devices for the lot subject to this recall (removal), photocopy the completed BRF, place it in the box with the subject product(s), and affix the pre-paid authorized shipping label included with this recall (removal) notification letter. Ethicon will pay for the shipping charges only if the authorized label is used. Extra shipping labels may be obtained by calling Stericycle at 1-877-597-9582 and referencing Event 4528. Your JJHCS number and mailing address have been pre-populated on the BRF. Distributors were instructed to: 1. E

Device

Device Recall Evicel Accessory Device
  • Model / Serial
    Lot 17-0102
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The device was distributed to the following states: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, PA, TN, TX, WA, WI, and WV. The device was also distributed to Puerto Rico.
  • Product Description
    Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device.
  • Manufacturer
    Ethicon, Inc.

Manufacturer

Ethicon, Inc.
  • Manufacturer Address
    Ethicon, Inc., Us Highway 22 West, Somerville NJ 08876
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA