B. Braun Recalls Filtered Triple-Leg Extension Sets Due to Occlusion Risk
B. Braun Medical is recalling 1,900 Filtered Triple-Leg Extension Sets because they may become occluded or unable to prime.
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 is classified as FDA Class II, and the source text identifies a functional defect (occlusion/inability to prime) in a medical device without reporting specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling 1,900 units of Filtered Triple-Leg Extension Sets (Catalog number 477034). These sterile, single-use intravascular administration sets are used for direct injection, intermittent or continuous infusion, or aspiration of fluids and medications.
The recall was initiated after the company identified through complaints that the extension sets have the potential to become occluded or unable to prime. The affected lots are 00SL713784, 0061741483, 0061755034, and 0061755296.
The products were distributed nationwide in North Carolina and California. Healthcare facilities and consumers should stop using these specific lots and contact B. Braun Medical for further instructions or a replacement.
The recalled product
- Product
- Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications.
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 1,900
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 (4)
- Lot #: 00SL713784
- 0061741483
- 0061755034
- 0061755296
Distribution
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