Reprocessed 0.9mm rapid exchange atherectomy catheters recalled for sterile barrier breaches
Northeast Scientific is recalling 795 reprocessed 0.9mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
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: Scored 3 under the risk-of-harm criterion: a compromised sterile barrier on an intravascular device creates an infection risk, with no injuries reported.
Plain-English summary
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheters, model/catalog number R-410-154, are being recalled for potential breaches in the sterile barrier packaging, which compromises sterility assurance. The catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
The recall covers 795 units carrying UDI-DI 00850044399062, across all lot numbers still within their labelled shelf life. The product was distributed to California, Florida, Illinois, Kansas, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Pennsylvania, Tennessee, Texas and Virginia. The FDA has classified the action as Class II.
The enforcement record describes a loss of sterility assurance rather than confirmed contamination, and reports no injuries. Facilities should quarantine unexpired stock and follow the firm's instructions.
The recalled product
- Product
- NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model…
- Manufacturer
- Northeast Scientific Inc.
- Affected units
- 795
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 (2)
- Model No R-410-154
- UDI-DI 00850044399062
Distribution
Part of a larger recall action
This product is one of 8 recalled by Northeast Scientific 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 8 products in this recall →Related recalls
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