B Braun SAFSITE Injection Site Valve Recall for Leakage Risk
B Braun Medical Inc is recalling SAFSITE Injection Site valves due to a potential for leakage and backflow.
The agency’s classification
FDA (Devices): 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II due to a potential for leakage and backflow at the valve. The source text does not report any illnesses, injuries, or deaths.
Plain-English summary
B Braun Medical Inc is recalling 461,300 units of the SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP (Catalog Number: 415068). The recall is being conducted because of a potential for leakage and backflow at the Safsite valve.
The affected products were distributed worldwide, including in the United States (CA, FL, IL, IN, MN, NJ, NY, OH, PA, TX, WA) and in Australia, Germany, Malaysia, and New Zealand. The specific lot numbers involved are 0061968348 (Expiration Date: 31OCT2029) and 0061966913 (Expiration Date: 30SEP2029).
Healthcare providers and facilities should check their inventory for these specific catalog and lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.
- Manufacturer
- B Braun Medical Inc
- Category
- Medical Device — Injection Site
- Affected units
- 461,300
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 (5)
- Catalog Number: 415068
- Primary UDI-DI: 04022495769862
- Unit of Use UDI-DI: 4045928016067
- Lot Number (Expiration Date): 0061968348 (31OCT2029)
- 0061966913 (30SEP2029).
Distribution
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