Neuro Vascular Medical Kit Recalled for Sterilization Assurance Failure
American Contract Systems recalls the Neuro Vascular ANKV91A medical convenience kit due to inability to confirm sterilization. Affected units were distributed across MO, MN, MA, OH, and NE.
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: FDA Class II device with inability to verify sterilization assurance. No illnesses or injuries reported; the hazard is theoretical rather than confirmed. However, a vascular medical device without confirmed sterilization presents a significant infection risk.
Plain-English summary
American Contract Systems, Inc. is recalling the Neuro Vascular ANKV91A medical convenience kit, manufactured as a single unit. The company identified that a chart recorder in one of its controlled environment areas became inoperable, preventing proper monitoring of humidity levels during the manufacturing process.
Because the humidity readings were out-of-specification and the monitoring equipment failed, American Contract Systems cannot confirm that the product meets sterilization assurance requirements. This means the company cannot verify that the device was properly sterilized as required for safe use.
The affected product is identified by UDI-DI 00191072201232, Lot 2405102, with an expiration date of May 10, 2025. The recall affects units distributed across MO, MN, MA, OH, and NE. Consumers or healthcare providers who have this device should contact American Contract Systems for instructions on returns or replacements.
The recalled product
- Product
- Neuro Vascular, ANKV91A; Medical convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Category
- Medical Device — Vascular
- Affected units
- 1
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 (3)
- UDI-DI: 00191072201232
- Lot: 2405102
- Exp: 05/10/2025
Distribution
Part of a larger recall action
This product is one of 19 recalled by American Contract Systems, 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.
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