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

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Q111009
FROM
QUAD SERVICE MMQC FT DETRICK MD//USAMMA/AFMLO/NMLC//
 
***PRIORITY***MESSAGE RELEASED:
01/10/2011
 
****************UNCLASSIFIED****************
 
SUBJ: MMQC-11-1009
TRIAD
MEDICAL / ALCOHOL SWAB STICKS / ALCOHOL PREP PADS / ALCOHOL SWABS / FDA MEDWATCH / SUSPEND
SUSPECT PRODUCTS
 



       

 
 
 
01. EXCERPT FROM FDA MEDWATCH.

HARTLAND,
WISCONSIN, TRIAD GROUP, A MANUFACTURER OF OVER-THE-COUNTER PRODUCTS 
HAS INITIATED A VOLUNTARY
PRODUCT RECALL INVOLVING ALL LOTS OF ALCOHOL PREP 
PADS, ALCOHOL SWABS, AND ALCOHOL SWABSTICKS
MANUFACTURED BY TRIAD GROUP BUT 
WHICH ARE PRIVATE LABELED FOR MANY ACCOUNTS TO THE CONSUMER
LEVEL. THIS RECALL 
INVOLVES THOSE PRODUCTS MARKED AS STERILE AS WELL AS NON-STERILE PRODUCTS.
THIS RECALL HAS BEEN INITIATED DUE TO CONCERNS FROM A CUSTOMER ABOUT POTENTIAL
CONTAMINATION OF THE PRODUCTS WITH AN OBJECTIONABLE ORGANISM, NAMELY BACILLUS 
CEREUS. WE ARE,
OUT OF AN ABUNDANCE OF CAUTION, RECALLING THESE LOTS TO ENSURE 
THAT WE ARE NOT THE SOURCE OF
THESE CONTAMINATION ISSUES.

USE OF CONTAMINATED ALCOHOL PREP PADS, ALCOHOL SWABS OR ALCOHOL
SWABSTICKS 
COULD LEAD TO LIFE-THREATENING INFECTIONS, ESPECIALLY IN AT RISK POPULATIONS,
INCLUDING IMMUNE SUPPRESSED AND SURGICAL PATIENTS. TO DATE WE HAVE RECEIVED 
ONE REPORT OF A
NON-LIFE-THREATENING SKIN INFECTION.

ALCOHOL PREP PADS, ALCOHOL SWABS AND ALCOHOL SWABSTICKS
ARE USED TO DISINFECT 
PRIOR TO AN INJECTION. THEY WERE DISTRIBUTED NATIONWIDE TO RETAIL
PHARMACIES 
AND ARE PACKAGED IN INDIVIDUAL PACKETS AND SOLD IN RETAIL PHARMACIES IN A BOX 
OF
100 PACKETS. THE AFFECTED ALCOHOL PREP PADS, ALCOHOL SWABS AND ALCOHOL SWABSTICKS 
CAN BE
IDENTIFIED BY EITHER "TRIAD GROUP," LISTED AS THE MANUFACTURER, OR THE 
PRODUCTS ARE
MANUFACTURED FOR A THIRD PARTY AND USE THE NAMES LISTED BELOW 
IN THEIR PACKAGING:
CARDINAL HEALTH
PSS SELECT
VERSAPRO
BOCA/ ULTILET
MOORE MEDICAL
WALGREENS
CVS
CONZELLIN
THESE PRODUCTS WERE DISTRIBUTED IN THE UNITED STATES, CANADA AND EUROPE.

SPECIFIC
CUSTOMERS DISTRIBUTING THE PRODUCT AND SELLING IT AT THE WHOLESALE, 
HOSPITAL AND RETAIL
PHARMACY LEVEL HAVE BEEN NOTIFIED BY CERTIFIED MAIL WITH 
INSTRUCTIONS ON HOW TO RETURN THE
PRODUCT. IF A CONSUMER HAS ANY OF THESE TYPES 
OF PRODUCTS IN THEIR POSSESSION LISTING "TRIAD
GROUP" AS THE MANUFACTURER, 
THEY SHOULD NOT USE THE PRODUCT AND SHOULD RETURN IT TO THE PLACE
IT WAS PURCHASED 
FOR A FULL REFUND OR CALL TRIAD GROUP CUSTOMER SERVICE MONDAY THROUGH FRIDAY
BETWEEN THE HOURS OF 8:30 A.M. AND 4:00 P.M. CENTRAL TIME: 262.538.2900.

DO NOT RETURN THE
PRODUCT ON YOUR OWN, SIMPLY CALL THE TRIAD GROUP CUSTOMER 
SERVICE LISTED BELOW AND WE WILL
ISSUE YOU A RETURN AUTHORIZATION NUMBER AND 
MAKE ALL RETURN ARRANGEMENTS.

ADVERSE
REACTIONS OR QUALITY PROBLEMS EXPERIENCED WITH THE USE OF THIS PRODUCT 
MAY BE REPORTED TO THE
FDA'S MEDWATCH ADVERSE EVENT REPORTING PROGRAM EITHER 
ONLINE, BY REGULAR MAIL OR BY FAX.
-  ONLINE:HTTP://WWW.FDA.GOV/MEDWATCH/REPORT.HTM9
  -  REGULAR MAIL: USE POSTAGE-PAID,
PRE-ADDRESSED FORM FDA 3500 AVAILABLE 
AT: HTTP://WWW.FDA.GOV/MEDWATCH/GETFORMS.HTM10 MAIL TO
ADDRESS ON THE PRE-ADDRESSED 
FORM.
  -  FAX: 1-800-FDA-0178

THIS RECALL IS BEING
CONDUCTED WITH THE KNOWLEDGE OF THE U.S. FOOD & DRUG 
ADMINISTRATION.


 
02. PASS MSG TO
MEDICAL LOG OFCRS, CMD CHANNELS, CLINICAL STAFF, RISK MANAGERS,
HEALTHCARE PROFESSIONALS,
PEDIATRICS, 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: 301-619-4300, DSN: 343, FAX:
4468, 
E-MAIL: usarmy.detrick.medcom-usamma.mbx.quad-service-mmqc@mail.mil

ARMY MEMBERS MAY
SUBSCRIBE TO DODMMQC 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."

USAMMCE: 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
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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