Events

Recall of Device Recall Penner Patient Transfer/Lift System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Penner Mfg 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
    56977
  • Event Risk Class
    Class 2
  • Event Number
    Z-1918-2011
  • Event Initiated Date
    2009-01-19
  • Event Date Posted
    2011-04-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98911
  • 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
    Lift, patient, ac-powered - Product Code FNG
  • Reason
    Incomplete weld on the pillar mounting bracket.
  • Action
    The firm, Penner, sent an undated letter flagged "Important Safety Inspection: Action Required" via certified mail on January 19, 2009 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect the Penner Patient Transfer for any missing Welds of the Pillar Mounting Bracket; inspect the areas indicated in the enclosed photos to confirm the bracket is welded on all edges to the main frame of the base; complete the inspection, and complete and return the attached WELD INSPECTION RESULTS OF PENNER PATIENT TRANSFER form via fax to 402 694-5844 or mail to Penner Manufacturing Inc, 102 Grant Street, Aurora, NE 68818, Attn: Quality Assurance Manager. Penner stated in the letter, if welds are not complete (no weld), discontinue use and contact the Quality Assurance Manager at Penner Manufacturing immediately at 402-694-5003. If you have any questions, contact the Quality Assurance Manager at 402-694-5003.

Device

Device Recall Penner Patient Transfer/Lift System
  • Model / Serial
    Serial numbers 03050800801, 04050819003, 04050819002, 06050841101, 04050819004, 06050841102, 09050907401, 10050923801, 10050923802, 02060990901, 02060990902, 03061014901, 03061014902, 07061082504, 06061066602, and 12030508001.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and countries including: Canada and Mexico.
  • Product Description
    Penner Manufacturing Transfer Electric Superior end entry, Patient Transfer/Lift System, Models 386000-1. The firm name on the label is Penner Manufacturing Inc., Aurora, NE. || For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.
  • Manufacturer
    Penner Mfg Inc

Manufacturer

Penner Mfg Inc
  • Manufacturer Address
    Penner Mfg Inc, 102 Grant St Ste A, Aurora NE 68818-3200
  • Source
    USFDA