B. Braun Recalls Sterile IV Start Kits Due to Sterility Testing
B. Braun Medical is recalling 15,950 Sterile IV Start Kits because non-routine sterility testing returned positive results.
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 3/5 (High).
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: The recall involves a sterile medical device with positive sterility testing results, representing a risk of harm (infection) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
B. Braun Medical, Inc. is recalling 15,950 units of Sterile IV Start Kits. The recall was initiated after positive results were obtained from non-routine sterility testing commissioned by the manufacturer for the finished product of this specific lot.
The affected product is identified by Lot Number 361105, with an expiration date of 1/01/2017 and Product Catalog Number 375198. The kits are packaged in trays of 50 units per case and are described as convenience kits for IV start procedures.
The product was distributed nationwide to Georgia, Illinois, and Florida. The source text does not specify the exact number of units distributed to each state or the specific facilities receiving the product. Consumers and healthcare providers should check their inventory for this specific lot number and stop using the product if found.
The recalled product
- Product
- Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — IV Start Kits
- Affected units
- 15,950
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 Number 361105
- exp date 1/01/2017
- Product Catalog Number 375198
Distribution
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