Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Reported: December 13, 2023 Initiated: September 29, 2023 #Z-0484-2024
Product Description
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Reason for Recall
A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
Details
- Recalling Firm
- Atrium Medical Corporation
- Units Affected
- 2460 units (246 cases, 10 units/case)
- Distribution
- US: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TX
- Location
- Merrimack, NH
Frequently Asked Questions
What product was recalled? ▼
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.. Recalled by Atrium Medical Corporation. Units affected: 2460 units (246 cases, 10 units/case).
Why was this product recalled? ▼
A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 13, 2023. Severity: Moderate. Recall number: Z-0484-2024.
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