Open Heart A Pack recall
OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
Why was Open Heart A Pack 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 00191072184450 00191072221070 Lots 921241 70-051173 70-052439
- Product
- OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
- Recalling firm
- American Contract Systems Inc
- Quantity
- 54 kits
- Distribution
- US Nationwide distribution in the state of OH.
- Recall date
- March 26, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)