Thoracic Packs Recalled for Unconfirmed Sterilization Assurance by Manufacturer
American Contract Systems recalls 40 kits of Thoracic Packs (Models UTTC82Y and UTTC82AA-01) due to inability to confirm sterilization assurance was met. Unsterilized packs may lose functionality and delay emergency 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 an FDA Class II medical device recall where sterilization assurance requirements were not confirmed. The source text indicates possible loss of functionality and treatment delay, constituting a risk-of-harm product. Per the severity rubric, without reported illnesses or injuries, this qualifies as High (3).
Plain-English summary
American Contract Systems Inc. is recalling 40 kits of Thoracic Packs (Models UTTC82Y and UTTC82AA-01). The affected lot numbers are 954241, 921241, 889241, 70-051283, 70-052001, 70-052096, and 70-053233.
The manufacturer is unable to confirm that sterilization assurance requirements were met during manufacturing. Unconfirmed sterilization could result in loss of functionality or lack of product effectiveness, potentially leading to delays in patient treatment.
These products were distributed across the United States, with specific documented distribution in Ohio.
The recalled product
- Product
- THORACIC PACK , Model No UTTC82Y UTTC82AA-01
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device — Trauma Kit
- Affected units
- 40
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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