Events

Recall of Device Recall GasChex sterilization indicators

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Propper Mfg 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
    48969
  • Event Risk Class
    Class 2
  • Event Number
    Z-2330-2008
  • Event Initiated Date
    2008-02-07
  • Event Date Posted
    2008-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72429
  • 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, physical/chemical sterilization process - Product Code JOJ
  • Reason
    The firm discovered a production specification discrepancy that may cause the indicators to show an inaccurate result.
  • Action
    On 2/07/08, Propper Mfg. Co. sent URGENT: DEVICE RECALL letters (dated 2/07/08) to the direct consignees, informing them of the recall of the affected lots of Gas-Chex EO Indicator Strips. The letters also instructed them to: (1) check their inventory to determine if they have the recalled lots in stock; (2) discontinue use of the affected lots; (3) reprocess any unused packs that have been processed with the affected lots of Gas-Chex EO Indicator Strips with non-recalled lots or an alternative product from another supplier; (4) return the affected lots to Propper Manufacturing; (5) complete the enclosed form and return via fax to Propper Mfg. Propper Mfg. will send a postage-paid label and instruction for return of the product, and will ship replacement product as soon as possible. Propper also recommended that consignees review the risk associated with items that have been monitored with the subject chemical indicators although a sterilization cycle failure is unlikely due to equipment controls and other monitoring methods. For questions, please contact Propper at 1-800-832-4300 during regular business hours (9 am to 4:30 pm).

Device

Device Recall GasChex sterilization indicators
  • Model / Serial
    Reorder No. 269001; Lots 6081, 6043, 6021, 7042, and 7013
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Puerto Rico
  • Product Description
    Propper short gas-chex EO sterilization indicators, 250 strips per box, Reorder No. 269001, Propper Manufacturing Co., Inc., Long Island City, N.Y. 11101
  • Manufacturer
    Propper Mfg Co Inc

Manufacturer

Propper Mfg Co Inc
  • Manufacturer Address
    Propper Mfg Co Inc, 36-04 Skillman Avenue, Long Island City NY 11101-1730
  • Manufacturer Parent Company (2017)
    Propper Manufacturing Co Inc
  • Source
    USFDA