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
posted by Terry S. Singeltary Sr. at
12:34 PM
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