Baxter Healthcare Corporation: REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.

Is my product affected?

REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.

• UPC 07332414123055

Check against the official notice below — it lists the full affected range.

What happened

Baxter Healthcare Corporation has recalled approximately 1.2 million REVACLEAR 300 and REVACLEAR 400 dialyzers used to treat chronic and acute kidney failure through hemodialysis. The recalled units, distributed nationwide in the United States and internationally to Canada and Bermuda, may contain ruptured dialyzer fibers that could cause blood to leak during treatment. The affected lot numbers range from C419105401 through C419111701.

The source does not specify what remedy is available to consumers affected by this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.

Details from the source

Reason for recall: There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment. Distribution: US Nationwide Distribution and Internationally to: Canada and Bermuda. Quantity: 1249272 units Lot/code info: UDI 07332414123055 Lot Numbers: C419105401 C419105501 C419105601 C419105701 C419105801 C419105901 C419106001 C419106101 C419106201 C419106301 C419106401 C419106501 C419106601 C419106701 C419106801 C419106901 C419107001 C419107101 C419107201 C419107301 C419107401 C419107501 C419107601 C419107701 C419107801 C419107901 C419108001 C419108101 C419108201 C419108301 C419108401 C419108501 C419108601 C419108701 C419108801 C419108901 C419109001 C419109101 C419109201 C419109301 C419109401 C419109501 C419109601 C419109801 C419110001 C419110101 C419110201 C419110301 C419110401 C419110501 C419110601 C419110701 C419110801 C419111001 C419111101 C419111301 C419111501 C419111601 C419111701

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.2019-05-30
• Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.2019-05-30
• Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.2019-05-30
• Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.2019-05-30
• Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.2019-05-30

All FDA (Device enforcement) recalls