Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend
Asahi Kasei is recalling 152,016 REXEED hemodialyzers after identifying 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 adverse events have been observed, but the source explicitly states there is no sufficient information to conclusively link the events to the product, fitting the 'risk-of-harm products where injury has not yet been reported' or theoretical hazard criteria for a score of 3.
Plain-English summary
Asahi Kasei Medical Co., Ltd. is recalling 152,016 units of REXEED hemodialyzers. The affected products are dialysis filters distributed worldwide, including in the United States, Japan, and Germany.
The recall was initiated because 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 providers and patients using these specific lot numbers should stop using the recalled hemodialyzers and contact the manufacturer or their supplier for instructions on replacement or return.
The recalled product
- Product
- Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter
- Manufacturer
- Asahi Kasei Medical Co., Ltd., Okatomi Plant
- Category
- Medical Device — Dialysis Filter
- Affected units
- 152,016
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 (16)
- Lot numbers: 193S43
- 193V47
- 193W48
- 1948E
- 19494F
- 194J4S
- 194K4T
- 294N4U
- 296F6Q
- 29767F
- 297J7U
- 297U87
- 299199
- 29929X
- 29939Y
- and 299X9H
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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