Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Penner Patient Transfer/Lift System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Penner Patient Transfer/Lift System see related information
Date Initiated by Firm January 19, 2009
Date Posted April 08, 2011
Recall Status1 Terminated 3 on April 08, 2011
Recall Number Z-1913-2011
Recall Event ID 56977
Product Classification Lift, patient, ac-powered - Product Code FNG
Product Penner Manufacturing Bariatric Patient Transfer/Lift System, Cascade Transfer, Models 382500-1 (right entry). 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 09050908201, 11050949102, 09050908203, 09050908204, 01060954501, 11050949103, 01060954503, 01060954502, 01060954504, and 01060954505. 
Recalling Firm/
Manufacturer		 Penner Mfg Inc
102 Grant St Ste A
Aurora NE 68818-3200
For Additional Information Contact Dale M. Wall
402-694-5003
Manufacturer Reason
for Recall		 Incomplete weld on the pillar mounting bracket
FDA Determined
Cause 2		 Employee error
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.
Quantity in Commerce 10 lifts
Distribution Worldwide distribution: USA and countries including: Canada and Mexico.
Total Product Life Cycle TPLC 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.
-
-