Events

Recall of Device Recall GEHealthcare, Drapes and Sterile Covers

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems, LLC.

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
    51722
  • Event Risk Class
    Class 2
  • Event Number
    Z-1730-2009
  • Event Initiated Date
    2008-08-29
  • Event Date Posted
    2009-08-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81090
  • 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
    Protective Cover, Barrier - Product Code MMP
  • Reason
    Ge healthcare has found that the sterile products manufactured by contour fabricators, inc. (cfi) for ge healthcare (gehc) may have sterile seals that could be compromised during the shelf life of the products. this issue could result in the product not maintaining its sterile state.
  • Action
    Consignees were sent 8/29/08 a GE Healthcare "Urgent Recall Notice" dated August 15, 2008. The letter was addressed to Director / Manager of Radiology and Director of Surgery. The letter described the problem and provided a list of products, solutions and requested the return of the attached fax forms. In the event of any questions or concerns, a service team should be contacted at 800-874-7378 option #8.

Device

Device Recall GEHealthcare, Drapes and Sterile Covers
  • Model / Serial
    all codes
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Australia, Bahamas, China, Hong Kong, Italy, Japan, Korea, Mexico, Malaysia, Singapore, and El Salvador.
  • Product Description
    GE Healthcare, Drapes and Sterile Covers || PART NUMBER DESCRIPTION || 00-900352-01 DRAIN BAG W/HOSE (2000/2500) 2.0 PE MATERIAL || 00-900352-01-OEC STRL, BAG, DRAIN WITH PLASTIC CLIPS AND HOSE 2000,2500 || 00-900352-02 STRL, BAG, DRAIN WITH METAL TABS || 00-900493-03 COVER DISPOSABLE X-RAY TUBE || 00-900605-01 UROFAST DRAIN BAG (UROFAST ONLY) || 00-900605-01-OEC STRL, BAG, DRAIN, WITH HOSE, UROFAST || 00-900885-01 URO2600 DRAIN BAG 2.0 PE MATERIAL || 00-900885-01-OEC STRL, BAG, DRAIN, URO2600 || 00-900943-01 STRL, COVER, CARM, HALF BAG, 36X80, 90,94,76 || 00-900974-01 STRL, DRAPING, MINI-CARM, KYBRD, BLK FTSW, 6600 || 00-901072-01 URO 2600 DISPOSABLES PACK 2.0 PE MATERIAL || 00-901072-01-OEC STRL, PACK, DISPOSABLES, UROVIEW 2600 || 00-901169-01 12 TUBE DRAPE (36X36) 2.0 PE MATERIAL || 00-901169-01-OEC STRL, COVER, DISPOSABLE, 12 INCH TUBE 9600 || 00-901268-01 DRAPE,STERIQUIK, STANDARD&SUPER-; || C,9600/7700 || 00-901390-01 STRL, DRAPING, KEYBOARD, FOOTSWITCH, 20PACK, 6600 || 00-901391-01 STRL, DRAPE, C-ARM ONLY, 6600 || 00-901392-01 STRL, COVER, KEYBOARD, 66,68 || 00-901501-01 9600/9800/SUPER C DISPOSABLES PACK 2.0 PE MATERIAL || 00-901501-01-OEC STRL, PACK, DISPOSABLES, MODEL 9800, 20 PACK || 00-901581-01-OEC STRL, COVER, DISPOSABLE, IR REMOTE, 9600, 9800 || 00901588-01 12 C ARM DISPOSABLES PACK 2.0 PE MATERIAL || 00-901588-01-OEC STRL, PACK, DISPOSABLES, 12 INCH, 20 PACK SCD 9600 || 00-901761-01 STRL, DISPOSABLES PACK, UROVIEW 2800 || 00-901831-02 STRL, COVER, FLUOROTRAK MONITOR, || DISPOSABLE BOX 10 PER PKG || 00-901832-01 STRL, APIX, COVER, DISPOSABLE CONTROLPANEL COVERS, REPLACEMENT PART CASE OF 25 || 00-901917-01 STRL, DRAPE, C-ARM, 6800 || 00-901918-01 MINIVIEW 6800 C-ARM CONSUMABLES PACK GRAY FOOTSWITCH || 00-901918-01-OEC STRL, DRAPE, 20 PACK, 6800 || 00-902752-01 STRL, RUI COVERS 25 COVERS || 00-902753-01 STRL, PACK, DISPOSABLE, 9800MD, 9 INCH 20 PACKS || 00-902754-01 STRL, PACK, DISPOSABLE, 9800MD, 12 INCH 20 PACKS || 00-902776-01 STRL, DRAPE, VASCULAR || 00-902864-01 STRL, DRAPE, HALF, C ARM, 9800 9600 || 00-902934-01 STRL, DRAPE, WORKSTATION, 20 PER BOX, 9900 || 1003135 STRL, BAG, FLAT PANEL || E7009AE STRL, DRAPE, AFM/CFM PEDESTAL, 25 PER BOX || E7009AF STRL, DRAPE, AFM/CFM JOYSTICK, 50 PER BOX || E7009AG STRL, DRAPE, LARGE DOME BAG, 20 PER BOX || E7009AH STRL, DRAPE, MEDIUM DOME BAG, 20 PER BOX || E7009AJ STRL, DRAPE, SMALL DOME BAG, 20 PER BOX || Sterile EO, Distributed by GE Medical Systems, Milwaukee, WI 53201, Manufactured by Contour Fabricators, Inc. Fenton, MI 48430. || The disposable sterile product provide a sterile barrier between the imaging device and sterile surgical field.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • Manufacturer Address
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA