InfuTronix Nimbus Administration Set Recalled for Potential Tube Leakage
InfuTronix LLC is recalling Nimbus Administration Sets due to a potential for tube leakage. The recall affects 10,800 units distributed in Massachusetts.
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 medical device with a risk of harm (tube leakage) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
InfuTronix LLC is recalling the Nimbus Administration Set, Reference HS-004, UDI # 00817170020031. The product is used to administer fluids or medication from a container to a patient through a needle or a catheter. The recall is being conducted because of a potential for tube leakage.
The recall involves 10,800 units distributed in the state of Massachusetts. The affected lots are: Lot # 1805002 (Expiration Date 06/10/2021), Lot # 1712005 (Expiration Date 12/19/2020), Lot # 1710012 (Expiration Date 10/22/2020), and Lot # 1901003 (Expiration Date 01/07/2022).
Healthcare facilities and consumers should stop using the affected products and contact InfuTronix LLC for further instructions or a refund.
The recalled product
- Product
- Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.
- Manufacturer
- InfuTronix LLC
- Hazard
- Affected units
- 10,800
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 (8)
- 1) Lot # 1805002
- Exp Date 06/10/2021
- 2) Lot # 1712005
- Exp Date 12/19/2020
- 3) Lot # 1710012
- Exp Date 10/22/2020
- 4) Lot # 1901003
- Exp Date 01/07/2022
Distribution
Distributed in 1 state:
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