Penner Manufacturing Transfer Electric Bariatric with Scale, Patient Transfer/Lift System, Cascade Transfer, Models 3835

FDA device recall Z-1915-2011 · posted 2011-04-08 · Terminated

Recall details

Recalling firm

Penner Mfg Inc

Reason for recall

Incomplete weld on the pillar mounting bracket

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

FNG

Quantity affected

20 lifts

Distribution

Worldwide distribution: USA and countries including: Canada and Mexico.

Date initiated

2009-01-19

Date posted

2011-04-08

Date terminated

2011-04-08

Location

Aurora, NE