Import Alert 79-01

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(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).

Import Alert # 79-01
Published Date: 04/02/2021
Type: DWPE with Surveillance

Import Alert Name:

"Detention Without Physical Examination Plastic Bandages And Cotton Pads Due To Microbiological Contamination"

Reason for Alert:

NOTE: The revisions to this import alert dated 10/2/2014 replaces DIOP with DIO, updates the CDRH Import Branch name and contact information, updates contact information for the Office of Regulatory Science and provides additional information on the removal process. Changes are bracketed by asterisks (***).

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 Red List for this import alert.

Increased surveillance of similar products from other manufacturers appears warranted.

*** When a district encounters a shipment of medical product which is found violative for defects by FDA analysis, the shipment should be detained and a recommendation for detention without physical examination should be forwarded to *** DIO, Import Operations and Maintenance Branch, HFC-172. ***

*** For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Office of Regulatory Science at 301-796-6600.

For questions concerning these types of products or other compliance issues, contact CDRH/OC Imports Branch, 301-796-5500, or email: cdrhocimport@fda.hhs.gov.

For questions or issues involving import operations, contact the Division of Import Operations at (301) 796-0356, or email fdaimportsinquiry@fda.hhs.gov.

For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)."

If a firm, shipper or importer wishes to request removal from detention without physical examination, they should forward information supporting their request to FDA at the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or via email: Importalerts2@fda.hhs.gov ***

Product Description:

Plastic Bandages and Cotton Pads

Charge:

"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)]."

OASIS charge code - STERILITY

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)]."

OASIS charge code - DV QUALITY

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)].

OASIS charge code - LBLG ADVER

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


CANADA


Executive Promotions
Date Published : 09/16/2009
7 Ronald Dr , Montreal-ouest, QC CANADA
79 F - - RO Dressing
Date Published: 09/16/2009

Notes: Sterillized Adhesive Dressing (aprt of

79 K - - GX Tape And Bandage, Adhesive
Date Published: 09/16/2009

Notes: Sterillized Adhesive Dressing (aprt of

79 L - - RR Kit, First Aid
Date Published: 09/16/2009

Notes: Sterillized Adhesive Dressing (aprt of

Shanmark Medical Products Inc.
Date Published : 09/16/2009
10280 Ch De La Cote-De-Liesse , Lachine, Quebec CANADA
79 K - - GX Tape And Bandage, Adhesive
Date Published: 09/16/2009

Notes: Bandage; 03-29-2006


CHINA


Anji-Yuandong Medical Products Co Ltd
Date Published : 08/05/2016
Baofu Industrial Zone , Anji County , Houzhou City, Zhejiang CHINA
79 N - - AB Gauze/Sponge, Nonresorbable For External Use
Date Published: 08/05/2016

Desc: 2X5yd Stretch Bandage

79 N - - AB Gauze/Sponge, Nonresorbable For External Use
Date Published: 08/05/2016

Desc: 4" Compress Bandage

80 F - - QM Bandage, Elastic
Date Published: 08/05/2016

Desc: 2X5yd Stretch Bandage

80 F - - QM Bandage, Elastic
Date Published: 08/05/2016

Desc: 4" Compress Bandage

Chain Medical Products Co., Ltd.
Date Published : 01/14/2010
rm. 606, fl 6, sunlake plaza no. 312, 64 , renmin rd., jiangbei direct, , Ningbo, CHINA
79 K - - GX Tape And Bandage, Adhesive
Date Published: 01/14/2010

Desc: Superband First Aid Kit including Non-Woven Pads (Gauze Pads) and assorted bandatges

79 M - - HW Dressing, Compression
Date Published: 05/17/2012

Desc: Bandages
Notes: class II

79 N - - AB Gauze/Sponge, Nonresorbable For External Use
Date Published: 04/02/2021

Desc: Superband First Aid Kit including Non-Woven Pads (Gauze Pads) and assorted bandages
Notes: 01/14/2010

79 O - - HO First aid kit without drug
Date Published: 01/14/2010

Desc: Superband First Aid Kit including Non-Woven Pads (Gauze Pads) and assorted bandatges

80 F - - QM Bandage, Elastic
Date Published: 03/07/2019

Desc: Bandages
Notes: Class II; 5/17/2012

Derma Sciences Nantong Inc
Date Published : 10/23/2013
No. 24 Tongzhou Rd., Nantong , Dev. Zone , Economic/Tech., Jiangsu CHINA
79 N - - AC Dressing, Wound, Hydrophilic
Date Published: 10/23/2013

Desc: Non-Adherent 2'x3' Sterile Bandage

Dhp Co., Ltd
Date Published : 06/09/2014
1-5f Yongshengxiaoqu , Yiwu, CHINA
79 - - - -- General & Plastic Surgery
Date Published: 09/15/2014

Desc: All Sterile gauze and bandags products
Notes: DWPE only applies to gauze and bandage products that are labeled as sterile

80 - - - -- General Hospital/Personal Use
Date Published: 09/15/2014

Desc: All Sterile gauze and bandags products
Notes: DWPE only applies to gauze and bandage products that are labeled as sterile

Dongguan City Risen Medical Products Co., Ltd
Date Published : 06/04/2019
No. 7 Chuangye Industrial Park, Jianshazhou , Dongguan, Guangdong CHINA
79 O - - HO First aid kit without drug
Date Published: 06/04/2019

Desc: First Aid Kit with Sterile Gauze; Wound Dressing and Bandage Products
Notes: DWPE only applies to gauze; wound dressing and bandage products that are labeled as sterile

79 - - - -- General & Plastic Surgery
Date Published: 06/04/2019

Desc: First Aid Kit with Sterile Gauze; Wound Dressing and Bandage Products
Notes: DWPE only applies to gauze; wound dressing and bandage products that are labeled as sterile

80 - - - -- General Hospital/Personal Use
Date Published: 06/04/2019

Desc: First Aid Kit with Sterile Gauze; Wound Dressing and Bandage Products
Notes: DWPE only applies to gauze; wound dressing and bandage products that are labeled as sterile

Guangdong Provincial Light Industry
Date Published : 09/16/2009
Haikang County , Guangzhou, CHINA
79 K - - GX Tape And Bandage, Adhesive
Date Published: 09/16/2009

Notes: Sur-Stik Plastic Bandages

Jiangxi Medicines & Health Products I/E Corp.
Date Published : 09/16/2009
Foreign Trade Bldg. , No. 200 Zhan Qian West Rd , Nanchang, Jiangxi CHINA
79 E - - FQ Sponge, Gauze
Date Published: 09/16/2009

Notes: Abdominal Pads; 01-12-2007

79 N - - AB Gauze/Sponge, Nonresorbable For External Use
Date Published: 09/16/2009

Notes: Abdominal Pads; 01-12-2007

NANJING HIMED MEDICAL TECHNOLOGY CO., LTD
Date Published : 01/17/2017
NO. 8 Xiushan Road , Gubo Development Zone , Nanjing, Jiangsu CHINA
79 K - - GX Tape And Bandage, Adhesive
Date Published: 01/17/2017

Desc: Transparent Dressing With Window Sterile 4"x4 3/4"                    
Notes:                                                                                                                          

NINGBO CHINMED TECHNOLOGY CO., LTD
Date Published : 04/13/2016
Shengjiacun , Xiangshan Xian , Ningbo, Zhejiang CHINA
79 N - - AC Dressing, Wound, Hydrophilic
Date Published: 04/13/2016

Desc: Bordered Circular Fenestrated Foam Dressing
Notes: Gram positive rods and gram positive cocci

Ningbo Chinmed Technology Co. Ltd.
Date Published : 04/13/2016
No. 8 Yuanyang Roadhengjie Town , Yinzhou, CHINA
79 N - - AC Dressing, Wound, Hydrophilic
Date Published: 04/13/2016

Desc: Bordered Circular Fenestrated Foam Dressing
Notes: Gram positive rods and gram positive cocci

Ningbo Chinmed Technology Co. Ltd.
Date Published : 04/13/2016
315181 Hengjie Village , Hengjie Town , Yinzhou Ningbo, CHINA
79 N - - AC Dressing, Wound, Hydrophilic
Date Published: 04/13/2016

Desc: Bordered Circular Fenestrated Foam Dressing
Notes: Gram positive rods and gram positive cocci

Taizhoushi Baisheng Import & Export Trading Co., Ltd.
Date Published : 07/11/2014
No. 30-15 Qingnian South Rd , Taizhou, Jiangsu CHINA
79 N - - AB Gauze/Sponge, Nonresorbable For External Use
Date Published: 07/11/2014

Desc: Absorbent Sterile Pads
Notes: Problem(s); Mold

WELONG PLASTIC PRODUCTS CO, LTD
Date Published : 02/02/2015
No. 136 Hongtang Street Kaiyuan Road , Jiangbei , Ningbo, Zhejiang CHINA
79 K - - GX Tape And Bandage, Adhesive
Date Published: 03/01/2016

Desc: Clear Bandage
Notes: Problem; STERLITY

80 F - - QM Bandage, Elastic
Date Published: 02/02/2015

Desc: Assured Fabric Bandages

80 F - - QM Bandage, Elastic
Date Published: 07/24/2015

Desc: Clear Bandage
Notes: Problem; STERLITY

YIWU BANGMEI MEDICAL PRODUCTS
Date Published : 03/03/2015
D, Belyuan , NO. 10 Jing Sanlu; Yiwu , Jinhua, Zhejiang CHINA
79 K - - GX Tape And Bandage, Adhesive
Date Published: 03/01/2016

Desc: First Aid Kit
Notes: Problem(s); MOLD

79 K - - GX Tape And Bandage, Adhesive
Date Published: 03/01/2016

Desc: Waterproof Bandages

79 K - - GX Tape And Bandage, Adhesive
Date Published: 03/01/2016

Desc: Dressing Bandage

79 O - - HO First aid kit without drug
Date Published: 03/19/2015

Desc: First Aid Kit
Notes: Problem(s): MOLD

Yangzhou Super-Union Medical Material Co., Ltd.
Date Published : 05/18/2017
118 SOUTH XISHAN ROAD , CHENJI TOWN , YIZHENG, Jiangsu CHINA
79 K - - GX Tape And Bandage, Adhesive
Date Published: 05/18/2017

Desc: Sterile Adhesive Bandage (in First Aid Kit)
Notes: First aid kits are subject to DWPE only if they contain sterile adhesive bandages.

79 L - - RR Kit, First Aid
Date Published: 05/18/2017

Desc: Sterile Adhesive Bandage (in First Aid Kit)
Notes: First aid kits are subject to DWPE only if they contain sterile adhesive bandages.

79 N - - AB Gauze/Sponge, Nonresorbable For External Use
Date Published: 12/10/2018

Desc: Sterile Pads

79 O - - HO First aid kit without drug
Date Published: 05/18/2017

Desc: Sterile Adhesive Bandage (in First Aid Kit)
Notes: First aid kits are subject to DWPE only if they contain sterile adhesive bandages.

Yuyao Chengze Medical Supplies Factory
Date Published : 06/18/2015
Fengdongcun , Yuyao , Ningbo, Zhejiang CHINA
79 K - - GX Tape And Bandage, Adhesive
Date Published: 03/01/2016

Desc: Tape and Bandage
Notes: Assured Colored Bandages

Zhejiang Bangli Medical Products Co., Ltd
Date Published : 09/16/2009
Huachuan Block , 118 South of Yuegui Road , Yongkang City, Zhejiang CHINA
79 K - - GX Tape And Bandage, Adhesive
Date Published: 09/16/2009

Notes: Tape and Bandage Adhesive

80 F - - QM Bandage, Elastic
Date Published: 09/16/2009

Notes: Tape and Bandage Adhesive

Zhejiang Hongyu Medical Commodity Co., Ltd.
Date Published : 11/02/2015
NO.668 CHANHUA ROAD FOTANG TOWN INDUSTRIAL FUNCTIONAL AREA , People's Republic of China , Yiwu, Zhejiang CHINA
79 N - - AC Dressing, Wound, Hydrophilic
Date Published: 11/02/2015

Desc: Surgical Dressings

80 F - - QM Bandage, Elastic
Date Published: 11/02/2015

Desc: Bandages

Zhejiang Hongyu Medical Commodity Co., Ltd.
Date Published : 11/02/2015
NO.668 CHANHUA ROAD FOTANG TOWN INDUSTRIAL FUNCTIONAL AREA , People's Republic of China , Yiwu, Zhejiang CHINA
79 N - - AC Dressing, Wound, Hydrophilic
Date Published: 11/02/2015

Desc: Surgical Dressings

80 F - - QM Bandage, Elastic
Date Published: 11/02/2015

Desc: Bandages


GERMANY


Fabrik Gmbh Co Kg
Date Published : 09/16/2009
Postfach 1127 , Stolzenau, GERMANY
79 K - - GX Tape And Bandage, Adhesive
Date Published: 09/16/2009

Notes: Emerlastic Strips (extra long)


HONG KONG SAR


SUNWAY PHARMACEUTICAL CO. LTD.
Date Published : 09/16/2009
FLAT Q&R, 10 F BLOCK 2 KIN HO IND.BLDG. , 14-24 AV. BUIP 1 WAN STREET , FOTAN SHATIN NT, HONG KONG SAR
79 K - - GX Tape And Bandage, Adhesive
Date Published: 09/16/2009

Desc: Sure-Stik Plastic Bandages


INDIA


ABS Medicare Pvt. Ltd.
Date Published : 09/16/2009
5 Vinod Vatika, Manjalpur , Vadodara, Gujarat, INDIA
79 M - - GR Dressing, Wound And Burn, Interactive
Date Published: 09/16/2009

Notes: HiZel; Sterile Hydrogel Wound Dressing

79 N - - AE Dressing, Wound, Hydrogel
Date Published: 09/16/2009

Notes: HiZel, Sterile Hydrogel Wound Dressing


JAPAN


Sato Pharmaceutical Co., Ltd
Date Published : 07/20/2010
Ahc Building 1-5-27 , Tokyo, JAPAN
79 K - - GX Tape And Bandage, Adhesive
Date Published: 07/20/2010

Desc: Adhesive Bandage

80 F - - QM Bandage, Elastic
Date Published: 07/20/2010

Desc: Adhesive Bandage


KOREA (THE REPUBLIC OF)


White Medical Ind Inc
Date Published : 09/16/2009
905 Hansuh River Park , Seoul, KOREA (THE REPUBLIC OF)
79 K - - GX Tape And Bandage, Adhesive
Date Published: 09/16/2009

Notes: Adhesive Strip Bandages


MEXICO


Degasa, S.A. DE C.V
Date Published : 09/16/2009
Calle 40 Sur 280-B Civac, Jlutepec , Morelos, MEXICO
79 N - - AB Gauze/Sponge, Nonresorbable For External Use
Date Published: 04/02/2021

Desc: Gauze Absorbable
Notes: 06-23-2005

Laboratorios Jaloma S.A. de C.V.
Date Published : 09/16/2009
Calle Aquiles Serdan No. 438 , Guadalajara, Jalisco MEXICO
79 N - - AB Gauze/Sponge, Nonresorbable For External Use
Date Published: 09/16/2009

Notes: Cotton Pads


PAKISTAN


Arsons Industries
Date Published : 09/16/2009
Ali Heights, 9 Commercial Zone, Karim , Block, Allama Igbal Town , Lahore, PAKISTAN
79 K - - GX Tape And Bandage, Adhesive
Date Published: 09/16/2009

Notes: Plastic Bandages; Fabric Bandages