Import Alert 89-17

(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 # 89-17
Published Date: 07/22/2019
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Medical Devices That Appear To Be
Adulterated Because Their Quality Falls Below That Which They Purport Or Are
Represented to Possess"

Reason for Alert:

Note: The revision of this Import Alert, dated 07/19/2017, updates the “Reason for Alert” section. Changes are bracketed by asterisks (***).


This import alert represents the Agency’s current guidance to the Food and Drug Administration (FDA) field personnel regarding the manufacturer(s) and/or product(s) at issue. It does not create or confer any rights for any person, and does not operate to bind FDA or the public.

Under section 501(c) of the Federal Food, Drug, and Cosmetic Act (the Act), a device is adulterated if its quality falls below that which it purports or is represented to possess. The Food and Drug Administration (FDA) has collected and analyzed samples of various medical devices which have not met the quality level that they purported or were represented to possess, in accordance with acceptance criteria in a standard or in a manufacturer’s Quality System (QS) Regulation acceptance procedure. *** ***

Guidance:

Districts may detain without physical examination (DWPE) the specified products from the firms identified in the Red List of this import alert.

The field may submit a DWPE request to the Division of Import Operations (DIO); in accordance with Section 9-6 of the Regulatory Procedures Manual, there are some circumstances when one violative sample may support a recommendation for DWPE. DIO will forward the DWPE recommendation to CDRH for consideration. CDRH will evaluate the recommendation and determine whether the evidence substantiates the DWPE recommendation.

Forward background information, including analytical worksheets (including the applicable standard or the manufacturer's acceptance procedure), product labeling and entry documents to DIO. DIO will coordinate a review of all recommendations for DWPE with CDRH.

The importer may obtain release of a shipment detained without physical exam under this import alert by presenting documentation which establishes that the appearance of a violation has been removed, such as sample analyses performed by an independent testing laboratory demonstrating that each 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. Refer to ORA Laboratory Procedures Manual (LM), Volume III, Section 7 for guidance regarding private laboratories.

For guidance on removal from DWPE, refer to Food and Drug Administration's Regulatory Procedure Manual, Chapter 9, "Detention Without Physical Examination (DWPE)."

Any request to remove a firm or product listed on the Red List of this import alert should include documentation with sufficient evidence establishing that the conditions that gave rise to the appearance of a violation have been resolved and the agency has confidence that future entries will be in compliance with the Act. 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.

All requests for removal from detention without physical examination may be sent via E-mail to: Importalerts2@fda.hhs.gov ; or mail to:

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

Requests for removal from detention without physical examination will be referred by DIO to CDRH for evaluation.

For questions or issues involving import operations, contact the Division of Import Operations, Import Operations and Maintenance Branch at (301) 796-0356.

For questions or issues concerning sample preparation or analytical methodology, contact the Office of Regulatory Science at (301) 796-6600.

For questions concerning performance standards or other compliance issues, contact CDRH/OC Imports Branch at 240-402-4020, or email: cdrhocimport@fda.hhs.gov .

Product Description:

All medical devices

Charge:

For devices that appear to be adulterated because their quality falls below that which they are represented to possess, in accordance with acceptance criteria in a standard or a QS procedure:

"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)]

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


CHINA


HONSUN NANTONG COMPANY LTD
Date Published : 05/22/2019
Economic & Technical , NO. 8 Tongxing Road; Development Area , Nantong City, Jiangsu CHINA
74 D - - XQ Cuff, Blood-Pressure
Date Published: 05/22/2019

Desc: Aneroid Sphygmomanometer

Wenzhou Bokang Instrument Co., Ltd.
Date Published : 11/14/2017
NO. 1500 Haining Road, Haibin Longwan , ZHEJIANG PROV , Wenzhou, Zhejiang CHINA
74 D - - XN System, Measurement, Blood-Pressure, Non-Invasive
Date Published: 11/14/2017

Desc: Palm Sphygmomanometer
Notes:                                                                                                                                            

74 D - - XQ Cuff, Blood-Pressure
Date Published: 03/27/2019

Desc: Aneroid Sphygmomanometer

74 D - - XQ Cuff, Blood-Pressure
Date Published: 11/14/2017

Desc: Palm Sphygmomanometer
Notes:                                                                                                                                            

74 D - - XQ Cuff, Blood-Pressure
Date Published: 04/09/2019

Desc: Palm Type Aneroid Sphygmomanometer (w/o Cuff)
Notes:                                                                    


MEXICO


Covidien
Date Published : 08/04/2017
Calle 9 sur 1113 , Ciudad Industrial , Tijuana, Baja California MEXICO
78 F - - PD Tube, Feeding
Date Published: 08/04/2017

Desc: Kangaroo PVC Feeding Tube
Notes:                                                                                                                                                                                                                                                                                                                             

Davol Surgical Innovations
Date Published : 06/06/2019
Ave. Roberto Fierro No. 6408 , Parque Industrial Aeropuerto , Cd. Juarez, Chihuahua MEXICO
78 E - - ZD Catheter, Straight
Date Published: 07/22/2019

Desc: INTERMITTENT CATHETER; Female 6 in/15cm 14 FR/CH (4.7 mm) #51614S

78 E - - ZD Catheter, Straight
Date Published: 07/22/2019

Desc: INTERMITTENT CATHETER Male 16 in/40cm; 14FR/CH (4.7mm) #63614M

78 E - - ZD Catheter, Straight
Date Published: 07/22/2019

Desc: INTERMITTENT CATHETER W SLEEVE Male 16 in/40cm;18 FR/CH (6.0mm) #53618G

78 E - - ZD Catheter, Straight
Date Published: 07/22/2019

Desc: CATHETER MEC (Standard 36mm) #97236

78 E - - ZD Catheter, Straight
Date Published: 07/22/2019

Desc: INTERMITTENT CATHETER; Male 16 in/40cm; 12FR/CH (4.0 mm) #53312

78 K - - OD Catheter, Urological
Date Published: 07/22/2019

Desc: INTERMITTENT CATHETER; Male 16 in/40cm; 12FR/CH (4.0 mm) #53312

78 K - - OD Catheter, Urological
Date Published: 07/22/2019

Desc: INTERMITTENT CATHETER Male 16 in/40cm; 14FR/CH (4.7mm) #63614M

78 K - - OD Catheter, Urological
Date Published: 07/22/2019

Desc: INTERMITTENT CATHETER W SLEEVE Male 16 in/40cm;18 FR/CH (6.0mm) #53618G

78 M - - JC Catheter, Urological (Antimicrobial) and Accessories
Date Published: 07/22/2019

Desc: INTERMITTENT CATHETER; Female 6 in/15cm 14 FR/CH (4.7 mm) #51614S

78 N - - NX Device, Incontinence, Urosheath Type, Non Sterile
Date Published: 07/22/2019

Desc: CATHETER MEC (Standard 36mm) #97236

78 O - - HR Catheter care tray
Date Published: 07/22/2019

Desc: INTERMITTENT CATHETER; Female 6 in/15cm 14 FR/CH (4.7 mm) #51614S

Productos Para El Cuidado De La Salud
Date Published : 10/22/2018
Carretera Internacional KM. 6.5 , Terrazas Del Cid , Nogales, MEXICO
73 B - - SY Catheters, Suction, Tracheobronchial
Date Published: 10/22/2018

Desc: Tracheobronchial Suction Catheter (All Sizes)