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DOD Medical Materiel Quality Control Messages (MMQC)/Medical Materiel Information Messages (MMI) & Images

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Q111123
FROM
QUAD SERVICE MMQC FT DETRICK MD//USAMMA/AFMLO/NMLC//
 
***PRIORITY***MESSAGE RELEASED:
02/11/2011
 
****************UNCLASSIFIED****************
 
SUBJ: MMQC-11-1123
NEURO
RESOURCE GROUP, INC (NRG) / TRIAD GROUP / ALCOHOL PREP PADS / MFR RELEASE NOTICE / DLA 11-011K
01. EXCERPT FROM NEURO RESOURCE GROUP, INC PRESS RELEASE

FOR IMMEDIATE
RELEASE - FEBRUARY 7, 2011 -NEURO RESOURCE GROUP, INC. (NRG) 
HAS BECOME AWARE OF THE MARKET
RECALL OF TRIAD GROUP'S ALCOHOL PREP PADS, ALCOHOL 
SWABS, AND ALCOHOL SWABSTICKS MANUFACTURED
BY TRIAD IN THE UNITED STATES AND 
MARKETED UNDER VARIOUS BRAND NAMES,
(HTTP://WWW.FDA.GOV/SAFETY/RECALLS/UCM239219.HTM). THE TRIAD GROUP ALCOHOL 
PREP PADS ARE
CO-PACKAGED AND DISTRIBUTED WITH NRG DEVICES TO CUSTOMERS IN 
THE UNITED STATES AND
INTERNATIONALLY.

ACCORDING TO THE FOOD AND DRUG ADMINISTRATION'S (FDA) MEDWATCH
COMMUNICATION, 
THE RECALL WAS INITIATED DUE TO CONCERNS ABOUT POTENTIAL CONTAMINATION OF THE
TRIAD GROUP'S PRODUCTS WITH THE BACTERIA, BACILLUS CEREUS. THIS RECALL INVOLVES
THOSE
PRODUCTS MARKED AS STERILE AS WELL AS NON-STERILE. USE OF CONTAMINATED 
ALCOHOL PREP PADS,
ALCOHOL SWABS, AND ALCOHOL SWABSTICKS COULD LEAD TO 
LIFE-THREATENING INFECTIONS, ESPECIALLY
IN AT-RISK POPULATIONS, INCLUDING IMMUNE 
SUPPRESSED AND SURGICAL PATIENTS. "THE TRIAD WIPES
MAY ALSO BE LABELED
SELECT; SELECT MEDICAL PRODUCTS; PSS SELECT, OR PSS WORLD MEDICAL, INC.
THE 
SUBJECT TRIAD/SELECT ALCOHOL WIPES PREVIOUSLY PROVIDED WITH NRG DEVICES SHOULD 
BE
DISCARDED IMMEDIATELY." NRG IS CURRENTLY PROVIDING ALCOHOL WIPES THAT ARE 
NOT SUBJECT TO
RECALL.

IT IS IMPORTANT TO NOTE, THAT "NRG DEVICES ARE NOT CONTAMINATED AND MAY CONTINUE
TO BE USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE ALCOHOL WIPES WERE 
PROVIDED
STRICTLY AS A CLEANING CONVENIENCE." PATIENTS AND HEALTHCARE PROVIDERS 
SHOULD "NOT" USE THE
TRIAD/SELECT ALCOHOL PREP PADS PACKAGED WITH THESE DEVICES 
AND SHOULD INSTEAD USE AN
ALTERNATE ALCOHOL PREP PAD THAT IS NOT INVOLVED WITH 
THE TRIAD GROUP RECALL, OR ALTERNATIVELY
USE A GAUZE OR TISSUE PAD IN CONJUNCTION 
WITH 70% ISOPROPYL ALCOHOL FOR CLEANING FOR
REPLACEMENT WIPES, CUSTOMERS MAY 
CONTACT NRG CUSTOMER SERVICE AT 1-877-314-6500.

THE
COMPANY PLANS TO ISSUE A LETTER TO CUSTOMERS TO MAKE THEM AWARE OF THE 
TRIAD PRODUCT RECALL
AND THE NEED TO DISCONTINUE USE OF THE TRIAD ALCOHOL PREP 
PADS PACKAGED WITH NRG PRODUCTS.
FURTHER INFORMATION ABOUT THE TRIAD GROUP 
RECALL CAN BE FOUND ON THE FDA WEBSITE AT:
HTTP://WWW.FDA.GOV/SAFETY/MEDWATCH/SAFETYINFORMATION/SAFETYALERTSFORHUMANME
DICALPRODUCTS/UCM239319.

PATIENTS SHOULD CONSULT THEIR HEALTHCARE PROVIDER FOR FURTHER
INFORMATION. 
HEALTHCARE PROVIDERS WITH QUESTIONS MAY CONTACT NRG CUSTOMER SERVICE
AT
1-877-314-6500 BETWEEN THE HOURS OF 8 AM AND 5 PM CENTRAL TIME.

 
02. PASS MSG TO MEDICAL
LOG OFCRS, CMD CHANNELS, CLINICAL STAFF, RISK MANAGEMENT,
EMERGENCY ROOM STAFF, MED STAFF,
SUPPLY OFCRS, AND SUPPORTED ACTYS/CTRS.

03. AUTHORITY: DODD 5105.22 AND DODD 6025.13.
ADDITIONALLY:

A. ARMY: SEE ARMY REGULATION (AR) 40-61, 28 JANUARY 2005, CHAPTER 4, AND THE
DEPARTMENT OF THE ARMY SUPPLY BULLETIN (SB 8-75-11) FOR APPLICABLE POLICIES 
AND PROCEDURES.
B. AIR FORCE: AF ACTIVITIES WILL TAKE ACTION AS PRESCRIBED IN AFI 41-209, MEDICAL 
LOGISTICS
SUPPORT, CHAPTERS 3 AND 9. FOR MAJCOMS & NGB--THIS MSG HAS BEEN 
TRANSMITTED TO ALL DESIGNATED
SUBORDINATE MEDICAL ACTIVITIES. 

04. SERVICE SPECIFIC POCS ARE AS FOLS (FAX NOS. ARE
AVAILABLE 24 HRS);

ARMY: TELEPHONE COM: 301-619-4320, DSN: 343, FAX: 4468, 
E-MAIL:
usarmy.detrick.medcom-usamma.mbx.quad-service-mmqc@mail.mil

ARMY MEMBERS MAY SUBSCRIBE TO
DOD MMQC MESSAGES AND MANY OTHER TOPICS AT THE 
FOLLOWING WEBSITE:
HTTP://WWW.USAMMA.ARMY.MIL/ASSETS/APPS/NALA_QAWEB/NALA_INDEX.CFM 
CLICK ON "SUBSCRIBE TO MMQC
MESSAGES HERE."

USAMMC-E: TELEPHONE COM: 011-49-6331-86-7118/7181, DSN: 495-7118, FAX: 6218,
E-MAIL: USAMMCE_QA@AMEDD.ARMY.MIL

AIR FORCE: TELEPHONE COM: 301-619-4170, DSN: 343, FAX:
2557
EMAIL:  AFMOA.SGALC@DETRICK.AF.MIL

AIR FORCE MEMBERS MAY SUBSCRIBE TO THE DOD MMQC
MESSAGES AND RECEIVE EMAIL
NOTIFICATIONS DIRECTLY FROM USAMMA WHEN THEY ARE PUBLISHED AT THE
FOLLOWING
WEBSITE: HTTPS://MEDLOG.DETRICK.AF.MIL/, GO TO "SITE SETTINGS" AND CHECK
"SUBSCRIBE
TO MMQC MESSAGES."

NAVY: TELEPHONE COM: 301-619-3085, DSN: 343, FAX: 3087, 
EMAIL:
MMQC2@MED.NAVY.MIL

NAVY MEMBERS MAY SUBSCRIBE TO RECEIVE DODMMQC MESSAGES AT
HTTP://WWW.USAMMA.ARMY.MIL
CLICK ON "SUBSCRIBE TO MMQC MESSAGES."
Last Modified Date: 08/01/2014