Events

Recall of Device Recall Getinge Assure Accufast BI Test Pack w/ 25 Controls

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Steritec Products Mfc. Co., 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
    65473
  • Event Risk Class
    Class 2
  • Event Number
    Z-1826-2013
  • Event Initiated Date
    2013-06-10
  • Event Date Posted
    2013-07-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119712
  • 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
    Indicator, biological sterilization process - Product Code FRC
  • Reason
    Mesa labs, based out of bozeman, mt, informed steritec products, inc. of a product recall involving the eztest steam and smart-read biological indicators (bi) because the readout time is not in specification with the label claims.
  • Action
    The firm, SteriTec, sent all customers recall notifications via e-mail. The e-mail included a .pdf file of the recall notification letter entitled "URGENT: MEDICAL DEVICE RECALL" dated June 11, 2013. The letter described the product, problem and actions to be taken. The letter also informed customers of MesaLabs, "URGENT: MEDICAL DEVICE RECALL" letter dated June 7, 2013 to its customers. The customers were instructed to notify SteriTec products of receipt of this notification via email at: Jon@SteriTecproducts.com or fax to: 303-660-4213 Attn: Director Regulatory Affairs; examine the lot number printed on the packaging components; place affected items in hold and do not sell or distribute these lots; record inventory of all items remaining in your warehouse and all items that have been distributed; advise SteriTec of the status of all inventory you received used or unused, if you have distributed the affected product to other locations within your healthcare system, notify them immediately of this recall, ask them to provide inventory status and proceed with destruction or return via instructions provided in letter-If you have shipping questions, please contact SteriTec directly at 303-660-4201, or email us at: Info@SteriTecproducts.com, and also provide this notice to anyone in your facility that needs to be informed. Should you have any questions or concerns, please do not hesitate to contact Director of Regulatory Affairs and Quality Assurance or our offices at 303-660-4201. SteriTec's hours of operation are 7:30am Mountain Standard Time (MST) through 5:00pm MST.

Device

Device Recall Getinge Assure Accufast BI Test Pack w/ 25 Controls
  • Model / Serial
    Affected Biological Indicator Lot No.:121101-447 and 121101-444
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
  • Product Description
    Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639 || The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers.
  • Manufacturer
    Steritec Products Mfc. Co., Inc.

Manufacturer

Steritec Products Mfc. Co., Inc.
  • Manufacturer Address
    Steritec Products Mfc. Co., Inc., 74 Inverness Drive East, Englewood CO 80112-5114
  • Manufacturer Parent Company (2017)
    Steritec Product Mfg. Co. Inc.
  • Source
    USFDA