Baylis Medical Recalls NRG RF Transseptal Kits Due to Packaging Defect
Baylis Medical is recalling NRG RF Transseptal Kits because sterile packaging may be compromised during shipping, posing a remote risk of infection.
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 risk-of-harm product (infection risk) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Baylis Medical Company Inc. is recalling the NRG RF Transseptal Kit, including specific model numbers such as NTK-710-8545 and NTK-711-8555. The recall involves a total of 59,067 units, which includes both individual units and those sold in kits. The product was distributed throughout the 50 states and in Washington D.C.
The recall is being conducted because there is a remote potential for the sterile packaging of the transseptal guiding sheath to be compromised during shipping and handling. If a packaging defect is not identified and the product is used in a patient, there is a remote risk of infection.
Healthcare providers and facilities should stop using the affected kits and contact Baylis Medical for instructions on returning the product. Consumers are not directly affected as this is a medical device used in clinical settings.
The recalled product
- Product
- NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK-710-8545N, NTK-711-8545N and NTK-711-8555N.
- Manufacturer
- Baylis Medical Company Inc.
- Affected units
- 59,067
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 (14)
- All lot numbers of the following kit model numbers: NTK-710-8545
- NTK-710-8555
- NTK-711-8545
- NTK-711-8555
- NTK-711-8590
- NTK-P711-8545
- NTK-P711-8555
- NTK-710-8545S
- NTK-710-8555S
- NTK-711-8545S
- NTK-711-8555S
- NTK-710-8545N
- NTK-711-8545N
- and NTK-711-8555N.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Baylis Medical Company Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Baylis Medical Company Inc.
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