Events

Recall of Device Recall Richard Wolf Instrument Corporation

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Richard Wolf Medical Instruments Corp..

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
    74656
  • Event Risk Class
    Class 2
  • Event Number
    Z-2608-2016
  • Event Initiated Date
    2016-05-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148125
  • 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
    System, abortion, vacuum - Product Code HHI
  • Reason
    The distal end of the conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). these two parts are welded together to create one piece. in the impacted batches of product, the weld was improperly performed. as a result, the two pieces are not properly joined. this potential failure can result in the separation of the two pieces. the possible separation of these two components presents a potential risk to patients.
  • Action
    Customers impacted were notified via Urgent Medical Device Recall Letter dated 5/31/2016 via certified mail. The letter describes the reason for the recall. Richard Wolf Identified the following measures to be taken by the consignees: 1. Immediately examine your inventory and quarantine product subject to recall. Richard Wolf Medical Instruments Corporation strongly recommends not using the potentially defective products. Please make sure that all users of the aforementioned products become aware of this urgent safety information. 2. If you have further distributed this product, please identify your customers and immediately notify them about this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter, but must include instructions on what customers should do with the recalled product. 3. PLEASE COMPLETE ENCLOSED ANSWER FORM {even if the product is no longer in your inventory) and return the record to Richard Wolf Medical Instruments Corporation before June 17, 2016. Your return of the answer form will: " Confirm receipt of this safety information " Trigger a replacement order. Richard Wolf Medical Instruments Corporation will provide your facility with a return authorization number and shipping instructions and will bear the cost for shipping (returns to RWMIC and replacements to facility). 4. Please immediately inform Richard Wolf Medical Instruments Corporation of any adverse events. If the consignees have any questions they are asked to contact Lisa Williams, Regulatory Affairs Assistant at Richard Wolf Medical Instruments Corporation Richard Wolf Medical Instruments Corporation. Telephone: (847) 913-1113 Ext: 256 Telephone: (847) 913-1113 Ext: 225 Fax: (847) 913-0924 Fax: (847) 913-0924 Email : lwilliams@richardwolfusa.com Monday through Friday, 7:30AM to 4:00 PM CST. Monday through Friday, 9:00AM to 5:30 PM

Device

Device Recall Richard Wolf Instrument Corporation
  • Model / Serial
    Product number 8378.90 with Batch number 51005921 and Product number 8378.91 with Batch number 51005922
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. Consignees: AK, AL, AR, AZ, CA, CT, DC, FL, GA, IA, IL, KY, MA, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, TX, UT and VA.
  • Product Description
    Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes.
  • Manufacturer
    Richard Wolf Medical Instruments Corp.

Manufacturer

Richard Wolf Medical Instruments Corp.
  • Manufacturer Address
    Richard Wolf Medical Instruments Corp., 353 Corporate Woods Pkwy, Vernon Hills IL 60061-3110
  • Manufacturer Parent Company (2017)
    Richard Und Annemarie Wolf Stiftung
  • Source
    USFDA