| Class 2 Device Recall Penner Patient Transfer/Lift System | |
Date Initiated by Firm | January 19, 2009 |
Date Posted | April 08, 2011 |
Recall Status1 |
Terminated 3 on April 08, 2011 |
Recall Number | Z-1912-2011 |
Recall Event ID |
56977 |
Product Classification |
Lift, patient, ac-powered - Product Code FNG
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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. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Penner Mfg Inc 102 Grant St Ste A Aurora NE 68818-3200
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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 | Model 382000-1 - 117 lifts; Model 382000-1L - 29 lifts |
Distribution | Worldwide distribution: USA and countries including: Canada and Mexico. |
Total Product Life Cycle | TPLC Device Report |
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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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