Class II
Ongoing
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, NDC: 70006-500-01.
This recall is currently active, issued March 5, 2025. It was issued by Wuxi Medical Lnstrument Factory Co., Ltd..
- Recall Initiated
- February 12, 2025
- Posted
- March 5, 2025
- Recall Number
- D-0247-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 37,500 Boxes
- Firm Location
- Wuxi, China
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Distribution
FL
Lot / Code Info
Lot #s: 200830, Exp 08/29/2025; 210925, Exp 09/24/2026; 221225, Exp 12/24/2027.
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