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U.S. Department of Health and Human Services

Class 2 Device Recall Penner Patient Transfer/Lift System

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 Class 2 Device Recall Penner Patient Transfer/Lift Systemsee related information
Date Initiated by FirmJanuary 19, 2009
Date PostedApril 08, 2011
Recall Status1 Terminated 3 on April 08, 2011
Recall NumberZ-1922-2011
Recall Event ID 56977
Product Classification Lift, patient, ac-powered - Product Code FNG
ProductPenner Manufacturing Transfer Electric Pacific Chair, Patient Transfer/Lift System, Models 393000-1. 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.
Code Information Serial numbers 01050746601, 01050746602, 03050789301, 03050789302,  01050741301, 06050840901, 06050840902, 06050840903, 11040702801,  06050840904, 06050840906, 06050840905, 05061030401, 05061030402,  05061030403, and 05061030404 
Recalling Firm/
Manufacturer		 Penner Mfg Inc
102 Grant St Ste A
Aurora NE 68818-3200
For Additional Information ContactDale M. Wall
402-694-5003
Manufacturer Reason
for Recall		Incomplete weld on the pillar mounting bracket
FDA Determined
Cause 2		Employee error
ActionThe 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.
Quantity in Commerce16 lifts
DistributionWorldwide distribution: USA and countries including: Canada and Mexico.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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