Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1069-2010

CLAY ADAMS Dynac III Centrifuge, 120V, Model Number 420104 DYNAC III is a multi-purpose centrifuge, designed...

Becton Dickinson & Co / initiated 2009-08-17 / Terminated / root cause: manufacturing process

Becton Dickinson & Co. began a recall of CLAY ADAMS Dynac III Centrifuge, 120V, Model Number 420104 DYNAC III is a multi-purpose centrifuge, designed for clinical laboratories performing separations... on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1069-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
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.
Product code
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
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.
Root cause tag
manufacturing process
FDA root cause
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.
Product codes and lots
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