Reported Jan 17, 2024 · Ongoing
BD Recanalization System, REF: BDRECANSYSTEM
Bard Peripheral Vascular Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bard Peripheral Vascular Inc · 1625 W 3rd St Bldg 1 · Tempe, AZ · 85281-2438
Is this the product you have?
- BD Recanalization System
- REFBDRECANSYSTEM
- Lot codes and dates
- UDI-DI00801741202421
- Serial Numbers
403 of 403 codes
BSX000001BSX000002BSX000003BSX000004BSX000005BSX000006BSX000007BSX000008BSX000009BSX000010BSX000011BSX000012BSX000013BSX000014BSX000015BSX000016BSX000017BSX000018BSX000019BSX000020BSX000021BSX000022BSX000023BSX000024BSX000025BSX000026BSX000027BSX000028BSX000029BSX000030BSX000031BSX000032BSX000033BSX000034BSX000035BSX000036BSX000037BSX000038BSX000039BSX000040BSX000041BSX000042BSX000043BSX000044BSX000045BSX000046BSX000047BSX000048BSX000049BSX000050BSX000051BSX000052BSX000053BSX000054BSX000055BSX000056BSX000057BSX000058BSX000059BSX000060
- Amount recalled
- 403
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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