News & Press: Patient Safety

Recall Alert: Alcohol Prep Pads by Simple Diagnostics

Tuesday, December 5, 2017  
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SIS Patient Safety Alert 12/05/2017: Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics: Recall - Lack of Sterility Assurance and Other Quality Issues

 

This is an important alert from the Spine Intervention Society. SIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the Food and Drug Administration (FDAissues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. Neither SIS, nor the FDA endorse either the product or the company.

ISSUE: Simple Diagnostics is voluntarily recalling three lots of Pharmacist Choice Alcohol Prep Pads (UPC # 898302001050, NDC # 98302-0001-05), which were manufactured by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues. The affected lots are:

 

SD2070421201 (Exp. 12/2019)
SD2070420925 (Exp. 09/2019)
SD2070420601 (Exp. 12/2019)


The affected lots were distributed between 10/18/2016 and 07/19/2017.


The use of impacted Alcohol Prep Pads could result in adverse events such as infections.

 

BACKGROUND: Pharmacist Choice Alcohol Preps are supplied to distributors and pharmacies. Pharmacist Choice Alcohol Preps are used by health care professionals and patients for preparation of the skin prior to injection, as well as in first aid to decrease germs in minor cuts, scrapes and burns.

  

RECOMMENDATION: Simple Diagnostics is notifying its distributors and customers by issuing a “Dear Customer” letter and arranging for the return of all recalled products. Healthcare providers that have affected lots of Pharmacist Choice Alcohol Prep Pads that have been recalled should stop using the product and should return them to Simple Diagnostics.

 

Health professionals and consumers with questions regarding this recall can contact Simple Diagnostics at 1-877-342-2385.

  

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

  • Complete and submit the report Online: fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

 

Read the FDA MedWatch Safety Alert, including a link to the press release.

 

Source: U.S. Food and Drug Administration (FDA) Accessed: 12/05/2017


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