Events

Recall of Various Tissu-Trans Products

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Precise Medical Supplies.

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
    RC-2017-RN-01000-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01000-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Results from a visual examination performed on the packaging by the manufacturer shippert medical technologies has revealed that the seal integrity of specific tissu-trans product sterile packages cannot be assured prior to usage without a visual inspection of the seal. to date, shippert has not received any customer complaints or reports of serious injuries and/or deaths due to the lack of sterility.
  • Action
    1. Remove all affected products and store them in a separate area. These products must not come into clinical use. 2. Forward this letter to all staff members that need to be aware of this information letter and the initiated recall. 3. Contact Precise medical supplies customer service for any additional questions regarding return of the products. 4. Replacement product will be issued and sent for returned products.

Device

Various Tissu-Trans Products
  • Model / Serial
    Various Tissu-Trans ProductsMega Trans 1500Model Number: SH 3-TT-1500Lot Numbers: 61288, 61464Tissu Trans 100ccModel Number: SH 3-TT-FILTRON 100Lot Numbers: 12018, 12109Tissu Trans 1000Model Number: SH 3-TT-FILTRON 1000Lot Numbers: 12004, 61235Tissu Trans 250Model Number: SH 3-TT-FILTRON 250Lot Numbers: 12019, 61286, 61421Filtron 500Model Number: SH 3-TT-FILTRON 500Lot Numbers: 12002, 12046, 61363ARTG Number: 181259
  • Manufacturer
    Precise Medical Supplies

Manufacturer

Precise Medical Supplies
  • Source
    DHTGA