A #79-01, REVISION - 9/9/03 IMPORT ALERT# 79-01,""DETENTION WITHOUT PHYSICAL
EXAMINATION OF PLASTIC BANDAGES *** AND COTTON PADS *** DUE TO MICROBIOLOGICAL
CONTAMINATION", ATTACHMENT - 9/24/08
This import alert represents the Agency's current guidance to FDA field
personnel regarding the manufacturer(s) and/or product(s) at issue. It does
not create or confer any rights for or on any person, and does not operate to
bind FDA or the public.
This alert has been revised to include cotton pads. Changes are bracketed by
asterisks (***)
TYPE OF ALERT: Detention Without Physical Examination
PRODUCT: Plastic Bandages *** and Cotton Pads ***
PRODUCT CODE: 79KGX and *** 79NAB ***
PROBLEM: Non-Sterile Medical Device
PAF: MIC (Microbiological Hazards)
PER (Performance-GMP Violations)
LBL (Labeling)
OASIS CHARGE
CODE: STERILITY
DV QUALITY
LBLG ADVER
PAC: 82008
COUNTRY: See attachment
MANUFACTURER/
SHIPPER: See attachment
CHARGES: The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to be adulterated since
it consists in whole or in part of a filthy, putrid, or
decomposed substance namely potentially infectious
microorganisms. [Section 501(a)(1)].
OR
The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to be adulterated since
its purity and quality fall balls below that which it is
represented to possess [Section 501(c)]
In addition, the article appears to be misbranded because
its labeling is misleading in a particular, namely that it
fails to reveal facts (non-sterility) that are material with
respect to consequences which may result from the use of the
article according to the labeling, or advertising, or under
such conditions of use as are customary or usual. [Sections
502(a), 201(n)].
RECOMMENDING
OFFICE: DIOP HFC-170
REASON FOR
ALERT: Microbiological analysis by FDA's Winchester Engineering and
Analytical Center of various plastic bandages *** and cotton
pads *** revealed that they were contaminated with various
viable microorganisms using the U.S.P. Sterility Test
Method.
Compliance Policy Guide 300.400(7124.01) addresses
contamination of devices labeled as sterile. It indicates
that non sterile devices should be given top priority
because of the seriousness of the hazard posed by microbial
contamination of sterile products. Products such as these
are used over open wounds, non-sterile bandages *** and
cotton pads *** have the potential to cause serious
infections.
CDRH has also indicated that given the intended use of these
products, even if they may not be labeled as sterile, is
cause for concern in that they may cause serious infection
in some individuals due to the microbial contamination found
on them.
GUIDANCE: Districts may detain without physical examination products
from the manufacturers identified in the attachment to this
import alert.
Increased surveillance of similar products from other
manufacturers appears warranted.
For questions or issues concerning science, science policy,
sample collection, analysis, preparation, or analytical
methodology, contact the Division of Field Science at (301)
443-3320 or 3007.
FOI: No purging required.
KEYWORDS: Bandage, microorganisms, sterile, *** cotton pads ***
PREPARED BY: Stella Notzon, DIOP, (301) 443-6553
DATE LOADED
INTO FIARS: September 9, 2003
ATTACHMENT Revised 9/24/08
3M Consumer Health Care Nexcare Bandages Brights
3M Center Nexcare Bandages Waterproof
St. Paul, MN "Brand name" Ratatouille
FEI# 2131088 79K[][]GX
11/8/07
Degasa S.A. de C.V. Absorbent Gauze
Calle 40 Sur Lote 2 Manzana 2 79GEM
280-B Civac Jiutepec 6/22/05
Morelos, Mexico
FEI# 3004119120
Fabrik Gmbh Co., Kg. Emerlastic Strips,
Postfach 1127 Extra Long
Stolzenau, Germany 79K[][]GX
FEI# 3006197966 08/31/07
(Manufacturer)
Guangdong Provinvial Light Industry Sure-Stik Plastic Bandages
Guangzhou, China (Mainland) 79KGX
FEI# 1000167774 11/17/97
(Manufacturer)
Sunway Pharmaceutical Co., Ltd. Sure-Stik Plastic Bandages
Flat Q and R 9KGX
10 F Block 2 11/17/97
Kin Ho Ind. Bldg.
14-24 Av. Buip 1 Wan Street
Fotan Shatin Nt, Hong Kong
FEI# 3000984911
White Medical Adhesive Strip Bandages/79KGX
Industries, Inc. 9/9/99
905 Hansu River Park
Seoul, Korea
FEI# 1000657870
Haiwon Pharmaceutical Co., Ltd Plastic Bandages
246, So-Joo Ri 79KGX
Wong Sang-Eup 6/13/00
Yanangsan
Kyung Name Change
Korea 9/24/01
FEI# 3003024098
Haiwon Pharmaceutical Co., Ltd
949 So Joo Ri
Wong Sang Eup.
Yangsan
Kyung Nam
Korea
FEI# 1000536861
Arsons Industries Plastic Bandages,
(Head office) Fabric Bandages
2nd floor, Ali Heights 79KGX
9-Commercial Zone 8/12/02
Karim Block
Allama Igbal Town
Lahore-54570-Pakistan
FEI# 3003195462
(Manufacturer)
Jiangxi Medicines & Health Products Abdominal Pads
Imports and Exports Co., Ltd. 79NAB
Foreign Trade Bldg. 79GEM
No. 200 Zhanqian Road 79EFQ
Nanchang, China 1/12/07
FEI# 3004806757
3001697840
(Sterilizer)
AMD-Ritmed Inc.
aka A.R. Medicom, Inc.
1200 55th Ave.
Lachine, Quebec
Canada H8T 1A1
FEI# 3002677549
Laboratorios Jaloma S.A. de C.V. Cotton Pads
Aquiles Serdan # 438, CP 44380 79NAB
Guadalajara, Mexico 9/ /03
FEI# 3002600322
Shanmark Medical Products Inc. Bandage
10280 Cote-De-Liesse 79K[][]GX
Lachine, Quebec, Canada H8T 1A3 3/28/06
FEI# 3003562502
(Shipper)
Executive Promotions "Sterilized" Adhesive Dressing
4670 St. Catherines St. W. (part of "Ski-doo first aid kit)
Montreal, Canada H3Z1S5 79FRO, 79KGX, 79LRR
FEI# 3004202466 3/12/07
(Manufacturer)
ABS Medicare Pvt. Ltd. HiZel, Sterile Hydrogel
5 Vinod Vatika, Manjalpur Wound Dressing
Vadodara, Gujarat, India 79NAE, 79M[][]GR
FEI# 3005037178 4/13/07
Initial Distributor:
^
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Yongkang Bangli Medical Products Tape and Bandage Adhesive
Zhengjia Village, Xiangzhu Town 79KGX
Yongkang City, Zhejiang Province 80KGX
China 80FQM
FEI# 3007028032 9/24/08
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