Recall Z-1306-2015— Penner Mfg Inc
Class II · Terminated
Class II FDA medical device recall by Penner Mfg Inc, initiated 2015-01-30, terminated 2016-03-10. It names one FDA 510(k) clearance: K962288. Product: 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.. 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..
- Recalling firm
- Penner Mfg Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-01-30
- Terminated
- 2016-03-10
- Firm location
- Aurora, NE, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.