ViaMed Alcohol Prep Pads Recalled Due to Sterility and Manufacturing Issues
Rece International Corp. is recalling ViaMed Alcohol Prep Pads due to lack of sterility assurance and manufacturing process deviations. The affected product was distributed in Florida.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving lack of sterility assurance and cGMP deviations on a sterile medical product. No illnesses or injuries have been reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ViaMed Alcohol Prep Pads (70% Isopropyl Alcohol, sterile) manufactured by Wuxi Medical Instrument Factory Co., Ltd. are being recalled. The affected product consists of individual sterile alcohol preparation pads packaged in boxes of 100, with 37,500 boxes recalled in total. The product was distributed in Florida by Rece International Corp.
The recall was initiated due to lack of assurance of sterility and current Good Manufacturing Practice (cGMP) deviations observed at the manufacturing facility. Because these pads are designed for sterile medical use, any compromise to the sterility assurance poses a potential risk.
The recalled lots are: Lot #200830 (expiration 08/29/2025), Lot #210925 (expiration 09/24/2026), and Lot #221225 (expiration 12/24/2027), with NDC 70006-500-01.
Consumers and healthcare facilities that have this product should discontinue use. Contact Rece International Corp. or consult with your healthcare provider for further instructions regarding this recall.
The recalled product
- Product
- ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in China, Manufactured for: Rece International Corp., Miami Lakes, FL, 33014, USA, N
- Manufacturer
- Wuxi Medical lnstrument Factory Co., Ltd.
- Hazard
- sterility-defect
- cgmp-violation
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 (6)
- Lot #s: 200830
- Exp 08/29/2025
- 210925
- Exp 09/24/2026
- 221225
- Exp 12/24/2027.
Distribution
Distributed in 1 state:
- FL
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