BORN ON ARRIVAL KIT , Model No LLBN11B
Reported: March 26, 2025 Initiated: February 6, 2025 #Z-1341-2025
Product Description
BORN ON ARRIVAL KIT , Model No LLBN11B
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? ▼
BORN ON ARRIVAL KIT , Model No LLBN11B. 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-1341-2025.
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