Cardiac Surgical Training Kits Recalled for Sterilization Verification Failure
American Contract Systems Inc is recalling OPEN HEART A PACK surgical training kits (Models UTOH19AI, UTOH19AJ-01, UTOH19AJ-02) because sterilization assurance requirements cannot be confirmed. Lack of sterilization could impair functionality.
What this means for you
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 device recall of a risk-of-harm product (cardiac surgical training equipment) where sterilization assurance cannot be confirmed. No illnesses or injuries have been reported, and the hazard is unconfirmed potential loss of functionality.
Plain-English summary
American Contract Systems Inc is recalling OPEN HEART A PACK surgical training kits distributed nationwide in Ohio. The recalled models are UTOH19AI, UTOH19AJ-01, and UTOH19AJ-02. The manufacturer is unable to confirm that sterilization assurance requirements were met during production.
Sterile medical devices require sterilization to prevent infection and ensure proper functionality. If sterilization assurance cannot be confirmed, the kits may lose functionality or fail to operate as intended, potentially delaying or prolonging medical training or procedures.
No injuries or illnesses have been reported. Consumers who received these kits should discontinue use and contact American Contract Systems Inc for replacement or refund information.
The recalled product
- Product
- OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
- Manufacturer
- American Contract Systems Inc
- Affected units
- 54
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 00191072184450 00191072221070 Lots 921241 70-051173 70-052439
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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