BD Recanalization System, REF: BDRECANSYSTEM
Reported: January 17, 2024 Initiated: November 14, 2023 #Z-0676-2024
Product Description
BD Recanalization System, REF: BDRECANSYSTEM
Reason for Recall
Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart required messages to indicate the ten-minute maximum catheter use time has been exceeded, which may increase the risk of the device overheating or breaking.
Details
- Recalling Firm
- Bard Peripheral Vascular Inc
- Units Affected
- 403
- Distribution
- US: CA, OH, PA, NY, TX, NJ, MS, IL, GA, AL, AZ, NC, NV, PR, IN, MA, WI, KS, AR, FL, MD, IA, NE, LA, HI, MO, DE, DC, VA, NM, CO, KY, ME, MN
- Location
- Tempe, AZ
Frequently Asked Questions
What product was recalled? ▼
BD Recanalization System, REF: BDRECANSYSTEM. Recalled by Bard Peripheral Vascular Inc. Units affected: 403.
Why was this product recalled? ▼
Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart required messages to indicate the ten-minute maximum catheter use time has been exceeded, which may increase the risk of the device overheating or breaking.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 17, 2024. Severity: Moderate. Recall number: Z-0676-2024.
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