Recall Z-0676-2024
Bard Peripheral Vascular Inc · initiated November 14, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BD Recanalization System, REF: BDRECANSYSTEM
Codes / lots: UDI-DI: 00801741202421. Serial Numbers: BSX000001, BSX000002, BSX000003, BSX000004, BSX000005, BSX000006, BSX000007, BSX000008, BSX000009, BSX000010, BSX000011, BSX000012, BSX000013, BSX000014, BSX000015, BSX000016, BSX000017, BSX000018, BSX000019, BSX000020, BSX000021, BSX000022, BSX000023, BSX000024, BSX000025, BSX000026, BSX000027, BSX000028, BSX000029, BSX000030, BSX000031, BSX000032, BSX000033, BSX000034, BSX000035, BSX000036, BSX000037, BSX000038, BSX000039, BSX000040, BSX000041, BSX000042, BSX000043, BSX000044, BSX000045, BSX000046, BSX000047, BSX000048, BSX000049, BSX000050, BSX000051, BSX000052, BSX000053, BSX000054, BSX000055, BSX000056, BSX000057, BSX000058, BSX000059, BSX000060, BSX000061, BSX000062, BSX000063, BSX000064, BSX000065, BSX000066, BSX000067, BSX000068, BSX000109, BSX000110, BSX000111, BSX000112, BSX000113, BSX000114, BSX000115, BSX000116, BSX000117, BSX000118, BSX000119, BSX000120, BSX000121, BSX000122, BSX000123, BSX000124, BSX000125, BSX000126, BSX000127, BSX000128, BSX000129, BSX000130, BSX000131, BSX000132, BSX000133, BSX000134, BSX000135, BSX000136, BSX000137, BSX000138, BSX000139, BSX000140, BSX000141, BSX000142, BSX000143, BSX000144, BSX000145…
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.
FDA-determined cause: Process design
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
Details
- Recall number
- Z-0676-2024
- Initiated
- November 14, 2023
- Posted by FDA
- January 5, 2024
- Product code
- PDU – Catheter For Crossing Total Occlusions
- Quantity
- 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
- Recalling firm
- Bard Peripheral Vascular Inc, Tempe, AZ