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: 12/08/2025
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Topical/External Bandages, Dressings, Gauzes/Sponges and Cotton Pads Due to Microbiological Contamination"
Reason for Alert:
NOTE: The revision to this import alert, dated 10/01/2024, updates import alert title, reason for alert section, guidance section including agency contacts, product description section, charge section and PAFs. Changes are bracketed by asterisks (***).
***Microbiological analysis conducted by FDA's Winchester Engineering and Analytical Center on topical/external bandages, dressings, gauzes/sponges, and/or cotton pads demonstrate that devices were contaminated with viable microorganisms using the U.S.P. Sterility Test Method.
Compliance Policy Guide 300.400 (7124.01) addresses contamination of devices labeled and promoted as “Sterile” and are required to be marketed as “Sterile” in accordance with the applicable cleared premarket submission and/or device classification. It is limited to topical/external bandages, dressings, gauze/sponges and cotton pads intended for medical purposes to be placed directly on a patient’s wound to absorb exudate, to control bleeding or fluid loss, and cover/protect the wound against abrasion, fraction, desiccation, and contamination. Products such as these are intended for medical purposes to be placed externally, directly on a patient’s wound. Devices on this import alert may contain antimicrobial/antifungal agents. Products may require 510(k)s, and others are 510(k) exempt. Devices may be sold as stand-alone devices while others may be included in a kit. All devices should be regulated by CDRH and should not include combination devices where CDER or CBER are considered the lead regulatory Center.
When test analysis demonstrates the presence of microbial growth, these devices should be given top priority because of the serious hazard posed by microbial contamination that has the potential to cause serious infections.***
***Microbiological analysis conducted by FDA's Winchester Engineering and Analytical Center on topical/external bandages, dressings, gauzes/sponges, and/or cotton pads demonstrate that devices were contaminated with viable microorganisms using the U.S.P. Sterility Test Method.
Compliance Policy Guide 300.400 (7124.01) addresses contamination of devices labeled and promoted as “Sterile” and are required to be marketed as “Sterile” in accordance with the applicable cleared premarket submission and/or device classification. It is limited to topical/external bandages, dressings, gauze/sponges and cotton pads intended for medical purposes to be placed directly on a patient’s wound to absorb exudate, to control bleeding or fluid loss, and cover/protect the wound against abrasion, fraction, desiccation, and contamination. Products such as these are intended for medical purposes to be placed externally, directly on a patient’s wound. Devices on this import alert may contain antimicrobial/antifungal agents. Products may require 510(k)s, and others are 510(k) exempt. Devices may be sold as stand-alone devices while others may be included in a kit. All devices should be regulated by CDRH and should not include combination devices where CDER or CBER are considered the lead regulatory Center.
When test analysis demonstrates the presence of microbial growth, these devices should be given top priority because of the serious hazard posed by microbial contamination that has the potential to cause serious infections.***
Guidance:
***Divisions may detain, without physical examination, the specific products from the manufacturers identified in the Red List for this import alert.***
***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 improper good manufacturer practices. If evidence indicates the product is compromised, product sampling may be considered on a case by case basis. Center concurrences is required prior to collection.***
*** Recommendation for addition to Detention Without Physical Examination and background information should be coordinated with CDRH Imports and Registration and Listing Team***
***Release of articles subject to detention without physical examination under this Import Alert:
In order to secure release of an individual shipment subject to detention without physical examination under this Import Alert, the owner, consignee and/or another responsible party to the shipment may provide documentation which establishes that the appearance of a violation has been removed, such as sample analyses performed by an independent testing laboratory demonstrating that shipment has met the criteria specified in the standard or QS acceptance procedure that the device is represented to meet. NOTE: To the extent that a manufacturer's QS acceptance procedure contains information that is exempt from disclosure under the Freedom of Information Act, FDA cannot provide such information to importers and private laboratories, and it is the importer's responsibility to obtain it.
Or submit to the FDA a written application (Form FDA 766) requesting authorization to bring a device that has been detained without physical examination per this import alert into compliance by relabeling or other action (reconditioning), or by rendering it other than a device. Divisions will refer such applications related to this alert to CDRH Imports and Registration and Listing Team via email at cdrhimport@fda.hhs.gov for concurrence.***
***Requests for removal from Detention without Physical Examination (REMOVE FROM RED LIST):
In order for FDA to consider removing a firm and/or product from detention without physical examination, FDA must have evidence which establishes the conditions that gave rise to the apparent violation have been resolved and which gives FDA confidence that future entries will be in compliance with the Act. Therefore, it is expected the firm, and/or an agent thereof will submit information outlining the firm's investigation into the root cause of the violation as well as any follow-up steps taken to prevent violations in future shipments. This may include a letter detailing its corrective actions accompanied by documentation. In addition, a minimum of five (5) consecutive non-violative commercial shipments should be entered before the agency may consider that the appearance of the violation has been overcome, and that it may be appropriate to remove a firm and product from the Red List for this import alert.
For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention Without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be sent via email to: Importalerts2@fda.hhs.gov
Questions or issues involving import operations or the submissions of petitions for removal from DWPE should be addressed to OII/DIO (301) 796-0356 or Imports@fda.hhs.gov.
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@fda.hhs.gov.
Questions concerning these types of products, and products intended exclusively for use upon animals (non-human) or other compliance issues, should be emailed to CDRH Imports and Registration and Listing Team at cdrhimport@fda.hhs.gov.
***
***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 improper good manufacturer practices. If evidence indicates the product is compromised, product sampling may be considered on a case by case basis. Center concurrences is required prior to collection.***
*** Recommendation for addition to Detention Without Physical Examination and background information should be coordinated with CDRH Imports and Registration and Listing Team***
***Release of articles subject to detention without physical examination under this Import Alert:
In order to secure release of an individual shipment subject to detention without physical examination under this Import Alert, the owner, consignee and/or another responsible party to the shipment may provide documentation which establishes that the appearance of a violation has been removed, such as sample analyses performed by an independent testing laboratory demonstrating that shipment has met the criteria specified in the standard or QS acceptance procedure that the device is represented to meet. NOTE: To the extent that a manufacturer's QS acceptance procedure contains information that is exempt from disclosure under the Freedom of Information Act, FDA cannot provide such information to importers and private laboratories, and it is the importer's responsibility to obtain it.
Or submit to the FDA a written application (Form FDA 766) requesting authorization to bring a device that has been detained without physical examination per this import alert into compliance by relabeling or other action (reconditioning), or by rendering it other than a device. Divisions will refer such applications related to this alert to CDRH Imports and Registration and Listing Team via email at cdrhimport@fda.hhs.gov for concurrence.***
***Requests for removal from Detention without Physical Examination (REMOVE FROM RED LIST):
In order for FDA to consider removing a firm and/or product from detention without physical examination, FDA must have evidence which establishes the conditions that gave rise to the apparent violation have been resolved and which gives FDA confidence that future entries will be in compliance with the Act. Therefore, it is expected the firm, and/or an agent thereof will submit information outlining the firm's investigation into the root cause of the violation as well as any follow-up steps taken to prevent violations in future shipments. This may include a letter detailing its corrective actions accompanied by documentation. In addition, a minimum of five (5) consecutive non-violative commercial shipments should be entered before the agency may consider that the appearance of the violation has been overcome, and that it may be appropriate to remove a firm and product from the Red List for this import alert.
For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention Without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be sent via email to: Importalerts2@fda.hhs.gov
Questions or issues involving import operations or the submissions of petitions for removal from DWPE should be addressed to OII/DIO (301) 796-0356 or Imports@fda.hhs.gov.
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@fda.hhs.gov.
Questions concerning these types of products, and products intended exclusively for use upon animals (non-human) or other compliance issues, should be emailed to CDRH Imports and Registration and Listing Team at cdrhimport@fda.hhs.gov.
***
Product Description:
***Topical/External Bandages, Dressings, Gauzes/Sponges and Cotton Pads***
Charge:
*** The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to consist in whole or in part of any filthy, putrid, or decomposed substance. [Adulteration, Section 501(a)(1)]
OASIS charge code - STERILITY
AND/OR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess. [Adulteration, Section 501(c)].
OASIS charge code - DV QUALITY
AND/OR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it 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. [Misbranding, 502(a), 201(n)].
OASIS charge code - LBLG ADVER ***
OASIS charge code - STERILITY
AND/OR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess. [Adulteration, Section 501(c)].
OASIS charge code - DV QUALITY
AND/OR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it 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. [Misbranding, 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, Wound, Drug
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
Hengjie Village Hengjie Town , Ningbo
, 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
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: 07/24/2015
Desc: Clear Bandage
Notes: Problem; STERLITY
80 F - - QM Bandage, Elastic
Date Published: 02/02/2015
Desc: Assured Fabric Bandages
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: Waterproof Bandages
79 K - - GX Tape And Bandage, Adhesive
Date Published: 03/01/2016
Desc: Dressing Bandage
79 K - - GX Tape And Bandage, Adhesive
Date Published: 03/01/2016
Desc: First Aid Kit
Notes: Problem(s); MOLD
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, Zhengjia Village , 118 South Of Yuegui Road; Xiangzhu Town
, Yongkang,
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
GERMANY
Fabrik Gmbh Co Kg
Date Published : 09/16/2009
Postfach 1127
, Stolzenau,
Lower Saxony 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 , Col. Oblatos, Guadalajara
, 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