Vein Tray Models UTVT21C Unable to Confirm Sterilization Assurance
American Contract Systems Inc is recalling certain Vein Tray models because sterilization assurance requirements could not be confirmed. The affected units may lack functionality and could lead to delayed 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 is a Class II medical device recall involving inability to confirm sterilization assurance. Per the severity rubric, it qualifies as High severity as a risk-of-harm product (medical device requiring sterility) where no injuries have yet been reported.
Plain-English summary
American Contract Systems Inc is recalling 48 kits of its Vein Tray (Model Nos. UTVT21C, UTVT21C02, UTVT21C-03) distributed in Ohio. The company is unable to confirm that product sterilization assurance requirements were met during manufacturing.
Without confirmed sterilization, the affected devices may not function properly and could lead to delayed or prolonged treatment for patients. Healthcare facilities using these devices should discontinue use of the recalled units immediately.
Affected units can be identified by UDI-DI 00191072205193 and lot numbers 70-051418, 70-052083, and 70-052850. Consumers and healthcare facilities with these lot numbers should contact American Contract Systems Inc for instructions on returning or replacing the affected products.
The recalled product
- Product
- VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device
- Affected units
- 48
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 00191072205193 Lots 70-051418 70-052083 70-052850
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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