Events

Recall of Device Recall Penner

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
    70151
  • Event Risk Class
    Class 2
  • Event Number
    Z-1306-2015
  • Event Initiated Date
    2015-01-30
  • Event Date Posted
    2015-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132324
  • 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
    Cover, barrier, protective - Product Code MMP
  • Reason
    If the patient sits on either wing, not squarely on the center section of the stretcher lift, tipping and injury to the operator or patient could result. the device manual was updated with an additional warning statement.
  • Action
    Beginning on 1/30/2015, the recalling firm sent letters via certified mail to their customers informing them of the change to the stretcher manual along with a revised manual which incorporated those changes. For questions regarding this recall call 402-694-5003.

Device

Device Recall Penner
  • Model / Serial
    Serial numbers: 01050741201, 01071198001, 01071198002, 01071198003, 01071198004, 01091136401, 01091136402, 01091136403, 01101314201, 01101322801, 01111505901, 02071228401, 02071228402, 02071228403, 02071228404, 02080975001, 02080975002, 02091137801, 02091149801, 02121713401, 03050791101, 03050804301, 03050804302, 03050804303, 03050804304, 03050804305, 03050804306, 03071247201, 03071247202, 03071247203, 03071247204, 03080984601, 03080984602, 03080984603, 03091161601, 03101347201, 03121742801, 03122862901, 04040581301, 04040581302, 04040581303, 04040581304, 04040581305, 04040581306, 04040581307, 04040581308, 04040581310, 04040581311, 04040581312, 04040581313, 04040581314, 04040586101, 04050810401, 04050810402, 04050810403, 04050810404, 04050810406, 04050810408, 04050810410, 04061028101, 04061028102, 04061028103, 04061028104, 04061028105, 04081009901, 04091187201, 04111563801, 04111568501, 05071272201, 05071272202, 05071272203, 05071272204, 05071272205, 05081019501, 05091197901, 05091197902, 05091201301, 05111513201, 05111576501, 05121762001, 06050840801, 06050840802, 06050840803, 06050840804, 06050840805, 06050840806, 06081037501, 06081039402, 06081039403, 06101394201, 07071320201, 07071320202, 07071328501, 07071328502, 07071328503, 07091223901, 07091223902, 07101410901, 07101415901, 08040660501, 08040660502, 08061090801, 08061090802, 08061090803, 08061090804, 08101430502, 08101439601, 09081073301, 09081074401, 09081076501, 09101453401, 09101457101, 09111641101, 09111641301, 10061121201, 10061121202, 10061121203, 10061121204, 10071396601, 10071396602, 10071396603, 10071396604, 10101463201, 10101464701, 10111652001, 11040710501, 11040710502, 11040710503, 11040710504, 11040710505, 11040710506, 11040710507, 11040710508, 11040710601, 11040710602, 11040710603, 11040710604, 11040710605, 11040710606, 11040710607, 11040710608, 11081101401, 11081105901, 11081113501, 11091285601, 11091285602, 11101475201, 11101476201, 11101476401, 11101477901, 11101478101, 12101495201, 12111677201, 12111686301, 12111686302, 12111688401, 03121734201S, 04040581301A
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Canada.
  • Product Description
    Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 || The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire (air bubbling) bathing system intended for use in nursing homes, hospitals, and assisted living facilities to transfer and/or lift patients under the direct supervision of trained staff. Model 392000-1 is equipped with a scale.
  • Manufacturer
    Penner Mfg Inc

Manufacturer

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