Import Alert 89-17

Import Alert # 89-17

Published Date: 03/11/2024

Type: DWPE

"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"

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

Note: The revision of this Import Alert, dated 08/14/2020, updates the Guidance section, Contact Information, and adds the OASIS charge code to the charge section. Changes are bracketed by asterisks (***).
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.

Divisions may detain, without physical examination, the specified products from the firms identified in the Red List of this import alert.

The division may submit a DWPE request to the Division of Import Operations (DIO); in accordance with Section ***9-8*** 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.

***Release of Articles Subject to Detention Without Physical Examination Under This Import Alert:***
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.

*** Removal from Detention without Physical Examination (REMOVE FROM RED LIST):

Foreign manufacturers listed on the Red List of this import alert who would like to request removal from that list should provide information to FDA to adequately demonstrate that the manufacturer has resolved the conditions and/or practices that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance. 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 DWPE, refer to Food and Drug Administration's Regulatory Procedure 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 forwarded to the following address:

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

Or, be sent via email to: Importalerts2@fda.hhs.gov ***

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

***Questions involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov

>>>Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at ORAOISMDSSISBImportSysProblemRpts@fda.hhs.gov>>>

Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov

Questions involving policy and/or sample collection recommendations should be addressed to CDRH Import Mailbox at cdrhimport@fda.hhs.gov.***

All medical devices

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)]

***OASIS Charge Code - DV QUALITY***

Desc: Ultrasound Lotions; ALL

Notes:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  

Desc: Ultrasound Gels; ALL

Notes:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  

Desc: Ultrasound Gels; ALL

Notes:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  

Desc: Ultrasound Lotions; ALL

Notes:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  

Desc: Ultrasound Gels; ALL

Notes:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  

Desc: Ultrasound Lotions; ALL

Notes:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  

Desc: Single Patient Use Aneroid Sphygmomanometer

Desc: Single Patient Use Aneroid Sphygmomanometer

Desc: Single Patient Use Aneroid Sphygmomanometer

Desc: Single Patient Use Aneroid Sphygmomanometer

Desc: Aneroid Sphygmomanometer

Desc: Electric Heating Pads Model MB-001 (NA-H1121B); Large (12" x 24") Blue Electric

Desc: Electric Heating Pads Model MB-002 (NA-H21C); Extra-Large (20" x 24") Blue Electric

Desc: Electric Heating Pads Model PE-MtyBls-HeatPad-12x24-Gry-V2(NA-H1121B); Large (12 x 24 ) Grey

Desc: Electric Heating Pads Model MB-002 (NA-H21C); Extra-Large (20" x 24") Blue Electric

Desc: Electric Heating Pads Model PE-MtyBls-HeatPad-12x24-Gry-V2(NA-H1121B); Large (12 x 24 ) Grey

Desc: Electric Heating Pads Model MB-001 (NA-H1121B); Large (12" x 24") Blue Electric

Desc: Electric Heating Pads Model MB-001 (NA-H1121B); Large (12" x 24") Blue Electric

Desc: Electric Heating Pads Model MB-002 (NA-H21C); Extra-Large (20" x 24") Blue Electric

Desc: Electric Heating Pads Model PE-MtyBls-HeatPad-12x24-Gry-V2(NA-H1121B); Large (12 x 24 ) Grey

Desc: Electric Heating Pads Model PE-MtyBls-HeatPad-12x24-Gry-V2(NA-H1121B); Large (12 x 24 ) Grey

Desc: Electric Heating Pads Model MB-002 (NA-H21C); Extra-Large (20" x 24") Blue Electric

Desc: Electric Heating Pads Model MB-001 (NA-H1121B); Large (12" x 24") Blue Electric

Desc: Verifine Insulin Syringe 31G 5/16 (1mL)

Desc: Verifine Insulin Syringe 31G 5/16 (1mL)

Desc: Palm Sphygmomanometer

Notes:                                                                                                                                            

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

Notes:                                                                    

Desc: Aneroid Sphygmomanometer

Desc: Palm Sphygmomanometer

Notes:                                                                                                                                            

Desc: Electric Heating Pads Model MB-002 (NA-H21C); Extra-Large (20" x 24") Blue Electric

Desc: Electric Heating Pads Model PE-MtyBls-HeatPad-12x24-Gry-V2(NA-H1121B); Large (12 x 24 ) Grey

Desc: Electric Heating Pads Model MB-001 (NA-H1121B); Large (12" x 24") Blue Electric

Desc: Electric Heating Pads Model PE-MtyBls-HeatPad-12x24-Gry-V2(NA-H1121B); Large (12 x 24 ) Grey

Desc: Electric Heating Pads Model MB-002 (NA-H21C); Extra-Large (20" x 24") Blue Electric

Desc: Electric Heating Pads Model MB-001 (NA-H1121B); Large (12" x 24") Blue Electric

Desc: Kangaroo PVC Feeding Tube

Notes:                                                                                                                                                                                                                                                                                                                             

Desc: Tracheobronchial Suction Catheter (All Sizes)

Desc: Gastrointestinal Tube Rectal

Desc: Tri Funnel Gastrostomy Tube 22F