Z-1912-2011
Penner Manufacturing Transfer Electric Cascade Patient Transfer/Lift System, Models 382000-1 (right entry)...
Penner Patient Care, Inc / initiated 2009-01-19 / Terminated / root cause: manufacturing process
Penner Mfg Inc began a recall of Penner Manufacturing Transfer Electric Cascade Patient Transfer/Lift System, Models 382000-1 (right entry) and 382000-1L (left entry). The firm name on the... on . The reason FDA records is "Incomplete weld on the pillar mounting bracket". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1912-2011
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Penner Patient Care, Inc
- Product
- Penner Manufacturing Transfer Electric Cascade Patient Transfer/Lift System, Models 382000-1 (right entry) and 382000-1L (left 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.
- Product code
- FNG Lift, Patient, Ac-Powered
- Reason for recall
- Incomplete weld on the pillar mounting bracket
- Root cause tag
- manufacturing process
- FDA root cause
- 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
- Model 382000-1 - 117 lifts; Model 382000-1L - 29 lifts
- Distribution
- Worldwide distribution: USA and countries including: Canada and Mexico.
- Product codes and lots
- Model 382000-1 - Serial numbers 07030456102, 05030435303, 07030456101, 07030456103, 05030435301, 09030479202, 09030479201, 09030479205, 11030501601, 07030456104, 11030501602, 11030501604, 12030507602, 12030507601, 12030507603, 11030501603, 09030479203, 12030507604, 11030501605, 12030509803, 07030435302, 12030509802, 12030507605, 12030509805, 01040535102, 01040535103, 06040623302, 06040623303, 01040535101, 06040623304, 07040635502, 07040635501, 07040635503, 06040623301, 07040635504, 07040635505, 07040635506, 07040635601, 07040635602, 07040635603, 07040635604, 08040665602, 07040635605, 08040665601, 07040635606, 08040665603, 08040665604, 12030509804, 08040665605, 09040678702, 09040678701, 09040678703, 09040678704, 11040712001, 11040712002, 11040712003, 11040712004, 11040712005, 01050741002, 01050741003, 01050741004, 01050741005, 02050756702, 02050756704, 02050756701, 03050798302, 03050798305, 03050790404, 02050756703, 03050798301, 03050790402, 03050798304, 03050790401, 03050798303, 03050790403, 06050840201, 06050840202, 06050840203, 06050840204, 06050840205, 06050840206, 06050840207, 03050790405, 06050840209, 08050884101, 06050840210, 08050884401, 08050884404, 10050924102, 10050924101, 10050924103, 10050924106, 11050939502, 10050924105, 11050939503, 10050924104, 11050939601, 11050939501, 11050939504, 11050939603, 11050939604, 02060988902, 11050939602, 02060988903, 06061061801, 02060988904, 02060988901, 06061061804, 09061105901, 08050884403, 08061096702, 08061096703, 10061134503, 06071297106, 07071328104, 06050840208, and 01050741001. Model 382000-1L - Serial numbers 03050798604, 03050798602, 2050756901, 03050798601, 06050845901, 03050798603, 06050867102, 08050884701, 06050845902, 06050867104, 06050867103, 08050884702, 08050884703, 08050884704, 01060954301, 01060971601, 01060954302, 01060971604, 01060971602, 01060971603, 02060989001, 02060989002, 06050867101, 02060989004, 02060989003, 02060989005, 02060989006, 06061061901, and 06061061902.
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