Class 2 Device Recall Prime Bed TL500 Bed Frame

• Date Initiated by Firm: February 02, 2011
• Date Posted: November 08, 2012
• Recall Status: Terminated on May 14, 2014
• Recall Number: Z-0270-2013
• Recall Event ID: 63083
• Product Classification: Bed, ac-powered adjustable hospital - Product Code FNL
• Product: AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512. Usage: Hospital Bed.
• Code Information: Model #TL500; Serial Number: 001, 002, 003, 004, 005, 006, 007, 010, 013, 014, 015, 016, 017, 018, 021, 022, 023, 024, 025, 026, 027, 028, 029, 030, 031, 032, 033, 034, 035, 039, 040, 041, 042, 043, 044, 045, 046, 047, 048, 049, 050, 052, 053, 054, 055, 056, 057, 058, 059, 060, 061, 062, 063, 064, 065, 070, 075, 081, 09350014, 09350015, 09350016, 09350017, 09350018, 09350021, 09350023, 09350025, 09350026, 09350027, 09350028, 09350029, 09350030, 09350031, 09350032, 09350033, 09350035, 09350038, 09350040, 09350041, 09350042, 09350045, 09350048, 09350049, 09350054, 09350055, 09350056, 09350057, 09350058, 09350059, 09350060, 09350062, 09350063, 09350064, 09350065, 09350066, 09350067, 09350068, 09350069, 09350070, 09350072, 09350074, 09350082, 09350085, 09350087, 09350088, 09350089, 09350090, 09350091, 09350092, 09430001, 09430002, 09430003, 09430004, 09430005, 09430006, 09430007, 09430008, 09430010, 09430013, 09430014, 09430015, 09430017, 09430019, 09430020, 09430021, 09430022, 09430024, 09430026, 09430027, 09430028, 09430029, 09430030, 09430032, 09430033, 09430034, 09430036, 09430037, 09430038, 09430039, 09430040, 09430041, 09430042, 09430043, 09430044, 09430045, 09430046, 09430047, 09430049, 09430050, 09430051, 09430052, 09430053, 09430054, 09430056, 09430057, 09430058, 09430059, 09430060, 09430061, 09430062, 09430063, 09430065, 09430066, 09463067, 09430068, 09430069, 09430070, 09430071, 09430072, 09430074, 09430075, 09430076, 09430077, 09430078, 09430079, 09430080, 09430081, 09430083, 09430085, 09430086, 09430087, 09430088, 09430089, 09430091, 09430093, 09430094, 09430097, 09430099, 09430100, 09520001, 09520002, 09520003, 09520004, 09520005, 09520006, 09520007, 09520008, 09520009, 09520011, 09520012, 09520013, 09520015, 09520017, 09520018, 09520019, 09520020, 09520021, 09520022, 09520025, 09520026, 09520027, 09520028, 09520029, 09520030, 09520031, 09520032, 09520033, 09520034, 09520035, 09520036, 09520037, 09520038, 09520039, 09520040, 09520041, 09520042, 09520043, 09520044, 09520045, 09520046, 09520047, 09520048, 09520049, 09520050, 10040001, 10040003, 10040004, 10040005, 10040006, 10040007, 10040008, 10040009, 10040010, 10040011, 10040012, 10040013, 10040014, 10040015, 10040016, 10040017, 10040028, 10040029, 10040030, 10040032, 10040033, 10040034, 10040035, 10040036, 10040037, 10040038, 10040039, 10040040, 10040041, 10040042, 10040043, 10040044, 10040045, 10040046, 10040047, 10040048, 10040049, 10040050, 10040051, 10040052, 10040053, 10040054, 10040055, 10040056, 10040057, 10040058, 10040059, 10040062, 10040063, 10040064, 10040065, 10040066, 10040067, 10040068, 10040069, 10040070, 10040071, 10040073, 10040074, 10040075, 10040076, 10040077, 10040078, 10400029, 10400050, 10400056, 10400057, 10400058, 10400059, 10400065, 10370016, 10370017, 10370018, 10370019, 10370020, 10370032, 10370033, 10370034, 10370035, 10370038, 10370052, 10370053, 10370054, 10370056, 10370060, 10370063, 10370078, 10370079, 10370080 , 09380031, 09380029, 09380064, 09380070, 09380089, 09380040, 09380038, 09380085, 09380045, 09380054, 09380060, 09380059, 09380058, 09380048, 09380042, 09380038, 09380069, 09380063, 09380067 & 09380065.
• Recalling Firm/ Manufacturer: Primus Medical LLC; 8401 Southern Blvd; Boardman OH 44512-6709
• For Additional Information Contact: Mr. Mark R. Shaw; 330-965-9681
• Manufacturer Reason for Recall: The "Retaining washers & Clevis Pins" provided with the AC -powered adjustable hospital beds may fail under certain circumstances. The pins at the top of the leg were disengaging from the channel. This may cause the bed frame to come off tracks or collapse.
• FDA Determined Cause: Equipment maintenance
• Action: The firm, Primus Medical LLC, sent an "Important Notification Relating to Primus Medical Product TL500" letter dated March 29, 2011 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to replace the "Retaining washers & Clevis Pins" with the "Clevis Pins & Bow Tie Cotter Pins" in the TL500-001 Service Pack provided with the letter in order to avoid any potential failure and/or bed collapse and to return the" Retaining washers & Clevis Pins" after the replacement procedure is performed. If you have any questions, or need assistance in performing the replacement, call 330-965-9681.
• Quantity in Commerce: 342 Beds
• Distribution: Nationwide distribution: USA including states of: AZ, IL, KY, MD, MI, OH, OR, PA, TX and VA.
• 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.