B. Braun Recalls WHIN Infusion Sets Due to Needle Protrusion Risk
B. Braun Medical is recalling WHIN Infusion Sets because the Huber needle tip may protrude from the needle guard, posing a safety risk to patients.
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 hazard involves a risk-of-harm product (needle protrusion) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
B. Braun Medical, Inc. is recalling the WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in), Catalog Number 471734. The recall involves 5,980 units distributed worldwide, including specific US states and Canada. The affected lots are 0061482060 and 0061486821, with expiration dates of 1/31/2021 and 02/28/2021, respectively.
The recall is due to a potential for the tip of the Huber needle to protrude from the needle guard. This defect could pose a safety risk during the infusion of solution or medication into implanted intravascular ports.
Healthcare facilities and consumers should stop using the affected infusion sets and contact B. Braun Medical for instructions on return or replacement. The product was distributed to states including IN, NV, MA, IL, AR, TX, OH, CA, GA, FL, MS, NJ, AL, PA, TN, KY, VA, and SC, as well as Canada.
The recalled product
- Product
- WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734. Usage: Infusion of solution/medication into implanted intravascular ports.
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — Infusion Set
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)
- Catalog Number 471734
- Lot Numbers: 0061482060 and 0061486821
- expiration dates :1/31/2021 and 02/28/2021
- respectively.
Distribution
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