Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trends
Asahi Kasei is recalling 30,408 REXEED hemodialyzers due to a negative trend in adverse events potentially linked to manufacturing changes.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device (hemodialyzer) with reported adverse events, but the source explicitly states there is no conclusive link to the product and no specific injuries or deaths are reported, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Asahi Kasei Medical Co., Ltd. is recalling 30,408 units of REXEED hemodialyzers. The affected products include lot numbers 193J3R, 193M3T, and 294Q57. These dialysis filters were distributed worldwide, including in the United States, Japan, and Germany.
The recall was initiated after the manufacturer became aware of a negative trend in the rate of adverse events that may be associated with a manufacturing change to certain lot numbers. The source text notes that there is currently no sufficient information to conclusively link these adverse events to the products.
Healthcare facilities and distributors should stop using the affected units and contact the recalling firm for instructions on return or disposal. Patients using these devices should consult their healthcare providers regarding the recall.
The recalled product
- Product
- Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter
- Manufacturer
- Asahi Kasei Medical Co., Ltd., Okatomi Plant
- Affected units
- 30,408
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot numbers: 193J3R
- 193M3T
- and 294Q57
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 7 recalled by Asahi Kasei Medical Co., Ltd., Okatomi Plant under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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