Simple Diagnostics Recalls Alcohol Prep Pads Due to Sterility Concerns
Simple Diagnostics is recalling 150,250 alcohol prep pads because the company cannot ensure they are sterile and due to cGMP deviations.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility for a medical product, which fits the criteria for a Severe rating (FDA Class II with potential for significant injury).
Plain-English summary
Simple Diagnostics, Inc. is recalling 150,250 units of Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile. The recall is being conducted because the company lacks assurance of the product's sterility and has identified Current Good Manufacturing Practice (cGMP) deviations.
The affected product is distributed by Simple Diagnostics in Winston Park, NY, and was distributed throughout the United States. The recall includes Lot # SD2070420925 with an expiration date of 09/2019, as well as Lot # SD2070421201 and Lot # SD2070420601, both with expiration dates of 12/2019.
Consumers and healthcare providers should stop using the affected alcohol prep pads and contact Simple Diagnostics for further instructions or a refund.
The recalled product
- Product
- Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC 98302-0001-05
- Manufacturer
- Simple Diagnostics, Inc.
- Affected units
- 150,250
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # SD2070420925 Exp. Date 09/2019
- and Lot # SD2070421201 and Lot # SD2070420601
- Exp. Date 12/2019
Distribution
Distribution scope not specified by the agency.
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