Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend
Asahi Kasei is recalling 1,536 REXEED hemodialyzers because of a negative trend in adverse events potentially linked to a manufacturing change.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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) where injury has not yet been conclusively reported or linked to the product, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Asahi Kasei Medical Co., Ltd. is recalling 1,536 units of REXEED-13 LX hemodialyzers. The affected units are identified by lot number 296S77. The company became aware of a negative trend in the rate of adverse events that may be associated with a manufacturing change to certain lot numbers of the products.
The recall covers products distributed worldwide, including the United States (specifically Tennessee) and Germany. Although the adverse events may be associated with the manufacturing change, the source text states there is no sufficient information to date to conclusively link these adverse events to the products.
Healthcare providers and patients should stop using the affected hemodialyzers and contact the manufacturer for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter
- Manufacturer
- Asahi Kasei Medical Co., Ltd., Okatomi Plant
- Category
- Medical Device — Hemodialysis
- Affected units
- 1,536
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 (1)
- Lot number: 296S77
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.
See all 7 products in this recall →Related recalls
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FDA (Devices) · 2012-09-26
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