Cardiovascular Surgical Device Components Recalled for Improper Sterilization
American Contract Systems recalls cardiovascular surgical device components that were subjected to improper ethylene oxide sterilization at excessive temperatures, potentially causing loss of functionality or drug efficacy.
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 FDA Class II recall involves surgical device components with potential loss of functionality and drug efficacy due to improper sterilization. No illnesses or injuries have been reported, and the hazards are theoretical rather than confirmed. Per the severity rubric, risk-of-harm medical products where injury has not yet been reported are classified as High (3).
Plain-English summary
American Contract Systems, Inc. is recalling Vasc. Open CVOR SJH surgical device components (84 cases, Lot Numbers 940231 and 974231) due to improper sterilization exposure.
During an internal investigation, the manufacturer identified that two components—an I.V. Catheter (part number 4252535-02) and Adhesive Dermabond (part number DHVM12)—were inadvertently subjected to the company's sterilization process at higher temperatures than approved by the component manufacturers. The components were also exposed to ethylene oxide (EO) at levels exceeding manufacturer specifications.
As a result, the affected components may have reduced or absent functionality, loss of drug efficacy (where applicable), or higher-than-specified ethylene oxide residuals. The recalled products were distributed in Florida and Iowa.
Consumers and healthcare providers should discontinue use of the affected components immediately and contact American Contract Systems for replacement or return instructions.
The recalled product
- Product
- Vasc. Open CVOR SJH, REF SJVO56B
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 84
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 00191072182869
- Lot Numbers: 940231
- 974231
Distribution
Part of a larger recall action
This product is one of 12 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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