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U.S. Department of Health and Human Services

Class 3 Device Recall CLAY ADAMS Dynac III Centrifuge

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  Class 3 Device Recall CLAY ADAMS Dynac III Centrifuge see related information
Date Initiated by Firm August 17, 2009
Date Posted March 11, 2010
Recall Status1 Terminated 3 on April 22, 2010
Recall Number Z-1069-2010
Recall Event ID 54076
Product Classification Cenrifuges (micro, ultra, refrigerated) for clinical use - Product Code JQC
Product CLAY ADAMS¿ Dynac¿ III Centrifuge, 120V, Model Number 420104

DYNAC III is a multi-purpose centrifuge, designed for clinical laboratories performing separations in hematology, chemistry, urinalysis, blood banking, microbiology and cytology.
Code Information Serial Number: 4510001, 4510002, 4510003, 4510004, 4510005, 4510006, 4510007, 4510008, 4510009, 4510010, 4510011, 4510012, 4510013, 4510014, 4510015, 4510016, 4510017, 4510018, 4510019, 4510020, 4510021, 4510022, 4510023, 4510024, 4510025, 4510026, 4510027, 4510028, 4510029, 4510030, 4510031, 4510032, 4510033, 4510034, 4510035, 4510036, 4510037, 4510038, 4510039, 4510040, 4510041, 4510042, 4510043, 4510044, 4510045, 4510046, 4510047, 4510048, 4510049, 4510050, 4510051, 4510052, 4510053, 4510054, 4510055, 4510056, 4510057, 4510058, 4510059, 4510060, 4510061, 4510062, 4510063, 4510064, 4510065, 4510066, 4510067, 4510068, 4510069, 4510070, 4510071, 4510072, 4510073, 4510074, 4510075, 4510076, 4510077, 4510078, 4510079, 4510080, 4510081, 4510082, 4510083, 4510084, 4510085, 4510086, 4510087, 4510088, 4510089, 4510090, 4510091, 4510092, 4510093, 4510094, 4510095, 4510096, 4510097, 4510098, 4510099, 4510100, 4510101, 4510102, 4510103, 4510104, 4510105, 4510106, 4510107, 4510108, 4510109, 4510110, 4510111, 4510112, 4510113, 4510114, 4510115, 4510116, 4510117, 4510118, 4510119, 4510120, 4520001, 4520002, 4520003, 4520004, 4520005, 4520006, 4520007, 4520008, 4520009, 4520010, 4520011, 4520012, 4520013, 4520014, 4520015, 4520016, 4530001, 4530002, 4530003, 4530004, 4530005, 4530006, 4530007, 4530008, 4530009, 4530010, 4530011, 4530012, 4530013, 4530014, 4530015, 4530016, 4530017, 4530018, 4530019, 4530020, 4540001, 4540002, 4540003, 4540004, 4540005, 4540006, 4540007, 4540008, 4540009, 4540010, 4540011, 4540012, 4540013, 4540014, 4540015, 4540016, 4540017, 4540018, 4540019, 4540020, 4540021, 4540022, 4540023, 4540024, 4540025, 4540026, 4540027, 4540028, 4540029, 4540030, 4540031, 4540032, 4540033, 4540034, 4540035, 4540036, 4540037, 4540038, 4540039, 4540040, 4540041, 4540042, 4540043, 4540044, 4540045, 4540046, 4540047, 4540048, 4540049, 4540050, 4540051, 4540052, 4540053, 4540054, 4540055, 4540056, 4540057, 4540058, 4540059, 4540060, 4540061, 4540062, 4540063, 4540064, 4540065, 4540066, 4540067, 4540068, 4540069, 4540070, 4540071, 4540072, 4540073, 4540074, 4550001, 4550002, 4550003, 4550004, 4550005, 4550006, 4550007, 4550008, 4550009, 4550010, 4550011, 4550012, 4550013, 4550014, 4550015, 4550016, 4560001, 4560002, 4560003, 4560004, 4560005, 4560006, 4560007, 4560008, 4560009, 4560010, 4560011, 4560012, 4560013, 4560014, 4560015, 4560016, 4570001, 4570002, 4570003, 4570004, 4570005, 4570006, 4570007, 4570008, 4570009, 4570010, 4570011, 4570012, 4570013, 4570014, 4570015, 4570016, 4570017, 4570018, 4570019, 4570020, 4570021, 4570022, 4570023, 4570024, 4570025, 4570026, 4570027, 4570028, 4570029, 4570030, 4570031, 4570032, 4570033, 4570034, 4570035, 4570036, 4570037, 4570038, 4570039, 4570040, 4570041, 4570042, 4570043, 4570044, 4570045, 4570046, 4570047, 4570048, 4580001, 4580002, 4580003, 4580004, 4580005, 4580006, 4580007, 4580008, 4580009, 4580010, 4580011, 4580012, 4580013, 4580014, 4580015, 4580016, 4580017, 4580018, 4580019, 4580020, 4580021, 4580022, 4580023, 4580024, 4580025, 4580026, 4580027, 4580028, 4580029, 4580030, 4580031, 4580032, 4590001, 4590002, 4590003, 4590004, 4590005, 4590006, 4590007, 4590008, 4590009, 4590010, 4590011, 4590012, 4590013, 4590014, 4590015, 4590016, 4590017, 4590018, 4590019, 4590020, 4590021, 4590022, 4590023, 4590024, 4590025, 4590026, 4590027, 4590028, 4590029, 4590030, 4590031, 4590032, 4590033, 4590034, 4590035, 4590036, 4590037, 4590038, 4590039, 4590040, 4600001, 4600002, 4600003, 4600004, 4600005, 4600006, 4600007, 4600008, 4600009, 4600010, 4600011, 4600012, 4600013, 4600014, 4600015, 4600016, 4600017, 4600018, 4600019, 4600020, 4600021, 4600022, 4600023, 4600024, 4610001, 4610002, 4610005, 4610006, 4610008
Recalling Firm/
Manufacturer
Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information Contact Kimberly Cartier
410-316-4000
Manufacturer Reason
for Recall
Medical laboratory centrifuge component may have been assembled incorrectly and cause disabling of the safety feature which prevents customers from opening the centrifuge while it is spinning.
FDA Determined
Cause 2
Nonconforming Material/Component
Action An "Urgent Product Recall" letter dated August 2009 was sent to the customers. The letter described the affected product, problem and the action to be taken by customers. The customers were advised to discontinue use of the centrifuge for repair or replacement with refurbished unit , provide an Excel file or a list with name, address and telephone number of end-users who were shipped this product from their distribution branches so that BD may inform them of the issue,and return the enclosed response form. For further assistance regarding product replacement and returns contact our Technical Services Department at 1-800-638-8663.
Quantity in Commerce 411 units
Distribution Worldwide distribution: USA and Mexico, Phillipines, Columbia, Chile, Ecuador, Venezuela, Puerto Rico, Canada and Singapore.
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.
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