Atrium Pneumostat Chest Drain Valve, Part Number 16100
Reported: October 6, 2021 Initiated: August 26, 2021 #Z-2592-2021
Product Description
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Reason for Recall
The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.
Details
- Recalling Firm
- Atrium Medical Corporation
- Units Affected
- 92,430 units
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Location
- Merrimack, NH
Frequently Asked Questions
What product was recalled? ▼
Atrium Pneumostat Chest Drain Valve, Part Number 16100. Recalled by Atrium Medical Corporation. Units affected: 92,430 units.
Why was this product recalled? ▼
The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 6, 2021. Severity: Moderate. Recall number: Z-2592-2021.
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