OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
Reported: March 26, 2025 Initiated: February 6, 2025 #Z-1339-2025
Product Description
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
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
- 90 kits
- Distribution
- US Nationwide distribution in the state of OH.
- Location
- Tiffin, OH
Frequently Asked Questions
What product was recalled? ▼
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I. Recalled by American Contract Systems Inc. Units affected: 90 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-1339-2025.
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