BZK Antiseptic Towelettes Recalled for Lack of Sterility Assurance
Taizhou Kangping Medical is recalling 3.85 million cartons of BZK Antiseptic Towelettes due to lack of assurance of sterility. The product is intended for external wound care by healthcare professionals.
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: FDA Class II recall involving a manufacturing control failure (lack of sterility assurance) on a sterile medical device intended for wound care. This represents a risk-of-harm product per the rubric, and while no illnesses have been reported in the source, the failure creates potential for infection in healthcare applications.
Plain-English summary
Taizhou Kangping Medical Science and Technology Co., Ltd. is recalling 3.85 million cartons of BZK Antiseptic Towelettes, Sterile, For External Use Only. The product contains benzalkonium chloride 0.13% and is manufactured in Taizhou, Jiangsu, China (NDC 71310-111-01).
The FDA issued this Class II recall due to lack of assurance of sterility. This is a manufacturing control failure that affects the sterility of the antiseptic towelettes, which are intended for professional healthcare use in wound care and skin preparation.
The recalled products were distributed in New York. The affected lot numbers are 220583459, 230553459, 232743459, 110523, 031524, 052224, and 247793459.
Healthcare facilities and professionals in possession of these products should cease use immediately and contact the manufacturer or their distributor for further instructions.
The recalled product
- Product
- BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per carton , For Professional use, Mfg by: Taizhou Kangping Medical, Taizhou, JiangSu, China, NDC: 71310-111-01
- Manufacturer
- Taizhou Kangping Medical Science And Technology Co., Ltd.
- Hazard
- lack-of-sterility
- manufacturing-defect
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 (7)
- Lot Numbers: 220583459
- 230553459
- 232743459
- 110523
- 031524
- 052224
- 247793459
Distribution
Distributed in 1 state:
- NY
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