BD Recanalization System, REF: BDRECANSYSTEM

FDA device recall Z-0676-2024 · posted 2024-01-05 · Open, Classified

Recall details

Recalling firm

Bard Peripheral Vascular Inc

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.

Action taken

On 11/14/23 recall notices were mailed and emailed to customers who were asked to do the following: 1) Discontinue use of affected product and immediately quarantine until ready to return for service activities. 2) Share this notification with all device users within your facility and network to ensure they are aware of this field action. This notification should also be shared with any organization where the potentially affected devices have been transferred. 3) Complete and return the response form via email to BDRC49@bd.com 4) Recalling firm will contact customers to coordinate product return for service. Customers with questions can call the firm's North American Regional Complaint Center at 1-844-823-5433, Say "Recall" when prompted M-F 8am - 5pm CT, or email productcomplaints@bd.com

Root cause

Process design

Status

Open, Classified

Product code

PDU

Quantity 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

Date initiated

2023-11-14

Date posted

2024-01-05

Location

Tempe, AZ

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