OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
Reported: March 26, 2025 Initiated: February 6, 2025 #Z-1359-2025
Product Description
OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
Reason for Recall
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Details
- Recalling Firm
- American Contract Systems Inc
- Units Affected
- 54 kits
- Distribution
- US Nationwide distribution in the state of OH.
- Location
- Tiffin, OH
Frequently Asked Questions
What product was recalled? ▼
OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02. Recalled by American Contract Systems Inc. Units affected: 54 kits.
Why was this product recalled? ▼
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 26, 2025. Severity: Moderate. Recall number: Z-1359-2025.
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