AV Fistula Kit Recall Due to Unconfirmed Sterilization Assurance
American Contract Systems Inc is recalling 90 AV Fistula kits because sterilization assurance requirements cannot be confirmed. Possible loss of functionality could delay or prolong patient treatment.
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: This Class II medical device recall involves unconfirmed sterilization assurance on vascular access devices. Per the severity rubric, this qualifies as 'risk-of-harm products where injury has not yet been reported,' warranting a High rating.
Plain-English summary
American Contract Systems Inc is recalling 90 AV Fistula kits (Model No UTAV77T) distributed in Ohio. The manufacturer was unable to confirm that product sterilization assurance requirements were met.
AV Fistula kits are medical devices used for vascular access in dialysis patients. Possible loss or lack of functionality could lead to delay or prolonged patient treatment.
The affected lots are: 961241, 890241, 70-051326, 70-051979, and 70-053058, with UDI-DI 00191072205179. Patients and healthcare providers with devices from these lots should contact American Contract Systems Inc for guidance on appropriate next steps.
The recalled product
- Product
- AV FISTULA , Model No UTAV77T
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device — Vascular Access
- Affected units
- 90
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 (1)
- UDI-DI 00191072205179 Lots 961241 890241 70-051326 70-051979 70-053058
Distribution
Part of a larger recall action
This product is one of 32 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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