Thursday, January 16, 2014

The Anspach Effort, Inc. RECALL FDA Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD) MARYLAND HOSTPITAL

Enforcement Report - Week of January 15, 2014

 
Enforcement Reports

 

4 - Product Detail Product Description Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.

 

Recall Number Z-0631-2014 Classification Class II Code Info Serial # 1934, 3135, 50229989-3, and 31496704 (BLACKMAX-N) Serial # 80017906 (Foot Control)

 

Product Distributed Qty 4 ( BLACKMAX-N) and 1 (Foot Control)

 

Reason For Recall Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD).

 

Event Detail Event Id 67131

 

Product Type Devices Status

 

Completed Recalling Firm The Anspach Effort, Inc. City Palm Beach Gardens State FL Country US

 

Voluntary / Mandated Voluntary: Firm Initiated Recall Initiation Date 2012-06-11

 

Initial Firm Notification of Consignee or Public Telephone Distribution Pattern

 

US Distribution: Maryland only.

 

 


 

 

 

Product Detail

 

Product Description  Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone. 

 

Recall Number  Z-0632-2014 

 

Classification  Class II 

 

Code Info  Serial # 50152011-14 (B-Blue-S) Serial # 31447408 (B-Green) 

 

Product Distributed Qty  1 B-Blue-S and 1 B-Green 

 

Reason For Recall  Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD). 

 

Event Detail

 

Event Id  67131 

 

Product Type  Devices 

 

Status  Completed 

 

Recalling Firm  The Anspach Effort, Inc. 

 

City  Palm Beach Gardens 

 

State  FL 

 

Country  US 

 

Voluntary / Mandated  Voluntary: Firm Initiated

 

Recall Initiation Date  2012-06-11 

 

Initial Firm Notification of Consignee or Public  Telephone

 

Distribution Pattern  US Distribution: Maryland only. 

 

 


 

 

Class 2 Recall

 

Anspach BLACKMAXN (Pneumatic motor) and Autolube III  see related information21

 

Date Posted January 06, 2014

 

Recall Status1 Open

 

Recall Number Z-0631-2014

 

Product Classification Motor, Surgical Instrument, Ac-Powered22 - Product Code GEY23

 

Product Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.

 

Code Information Serial # 1934, 3135, 50229989-3, and 31496704 (BLACKMAX-N) Serial # 80017906 (Foot Control)

 

Recalling Firm/

 

Manufacturer The Anspach Effort, Inc.

 

4500 Riverside Drive

 

Palm Beach Gardens, Florida 33410-4235

 

Manufacturer Reason

 

for Recall Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD). 

 

Action none. 

 

Quantity in Commerce 4 ( BLACKMAX-N) and 1 (Foot Control)

 

Distribution Distributed in the state of Maryland.

 

Total Product Life Cycle TPLC Device Report24 

 

 

--------------------------------------------------------------------------------

  

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.5525 

 

 


 

 

 

Synthes Anspach Mechanical Reprocessing Tray (MERET)

 

 

Device Description

 

Tray that facilitates reprocessing of Synthes Anspach devices in a mechanical cleaner.

 

DO NOT reprocess the following Synthes Anspach Devices in a mechanical cleaner.

 

– AutoLube

 

– eMax® System Consoles and Foot Controls

 

– iMRI Foot Control

 

– Powered Irrigation Pump

 

Indications For Use

 

Intended to securely hold the Synthes Anspach devices listed in Table 1 and Table 2 below while being reprocessed in a hospital’s mechanical cleaner.

 

Contraindications

 

– Do not use to reprocess any devices not listed in Table 1 and Table 2.

 

– Do not use to reprocess dissection tools. Dissection tools are disposable and SINGLE USE ONLY.

 

– Do not use in sterilization procedures.

 

 

snip...

 

Transmissible Spongiform Encephalopathies (TSE).

 

Anspach will not authorize or accept the return of products that directly contact patients or are contaminated with a patient’s body fluids who is suspected or confirmed with a Transmissible Spongiform Encephalopathies/ Creutzfeldt-Jakob Disease (TSE/CJD) diagnosis. Anspach recommends that all Anspach products used on a patient confirmed with a TSE/CJD diagnosis be incinerated. Anspach dissecting tools used on a patient suspected of TSE/CJD diagnosis must be incinerated. Contact your Sales Representative for replacement of product incinerated under this policy or for temporary equipment while original equipment is quarantined. Contact the Anspach Customer Service Department regarding TSE/CJD contamination for additional information. United States Federal law restricts this device to sale by or on order of a physician or other licensed healthcare provider.

 

 

 


 

 

 

Greetings prion world,

 

looks like NO ACTION TAKEN?

 

I wonder which hospital in Maryland this is, where this CJD incident took place ???

 

I wonder if there were any exposures to humans from this incident ???

 

if so, were the patients notified at this hospital ???

 

if not, why not ???

 

 

kind regards,

terry

 

 

 

 

Wednesday, January 15, 2014

 

INFECTION PREVENTION AND CONTROL OF CJD, VCJD AND OTHER HUMAN PRION DISEASES IN HEALTHCARE AND COMMUNITY SETTINGS Variably Protease-Sensitive Prionopathy (VPSPr) January 15, 2014

 


 

 

 

Wednesday, December 11, 2013

 

*** Detection of Infectivity in Blood of Persons with Variant and Sporadic Creutzfeldt-Jakob Disease

 


 


 

 

 

Monday, January 13, 2014

 

*** Prions in Variably Protease-Sensitive Prionopathy: An Update Pathogens 2013 Pathogens 2013, 2, 457-471; doi:10.3390/pathogens2030457

 


 

 

 

Friday, January 10, 2014

 

*** vpspr, sgss, sffi, TSE, an iatrogenic by-product of gss, ffi, familial type prion disease, what it ???

 


 

 

 

*** PRICE OF CWD TSE PRION POKER GOES UP 2014 ***

 

 

Wednesday, January 01, 2014

 

Molecular Barriers to Zoonotic Transmission of Prions

 

*** chronic wasting disease, there was no absolute barrier to conversion of the human prion protein.

 

*** Furthermore, the form of human PrPres produced in this in vitro assay when seeded with CWD, resembles that found in the most common human prion disease, namely sCJD of the MM1 subtype.

 


 


 

 

 

Saturday, November 16, 2013

 

Management of neurosurgical instruments and patients exposed to creutzfeldt-jakob disease 2013 December

 

Infect Control Hosp Epidemiol.

 


 

 

 

Thursday, November 14, 2013

 

Prion diseases in humans: Oral and dental implications

 


 

 

 

Saturday, November 2, 2013

 

Recommendation of the Swiss Expert Committee for Biosafety on the classification of activities using prion genes and prion protein January 2013

 


 

 

 

 

kind regards,

terry

 

 

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