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Terminated

Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter

FDA Recall Z-2421-2012 · Posted 2012-09-20

Recalling FirmAsahi Kasei Medical Co., Ltd., Okatomi Plant
Recall StatusTerminated
Product CodeKDI
Date Initiated2012-09-21
Date Terminated2013-02-05
Product Quantity80,208 units

Reason for Recall

Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.

Firm Action

AsahiKASEI Medical Co., LTD sent a Medical DeviceRecall letter on September 21, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to confirm that they have no inventory and to forward the letter to all clinics who may have received the product requesting they check their stock and arrange for the return of any recalled product. Non-responding consignees will be contacted by telephone. For questions regarding this recall call Asaki Kasei Medical America, Inc. at 888-362-6105.

Root Cause

Process change control

Distribution Pattern

REXEED SX: Worldwide Distribution - USA including TN and the countries of Japan and Germany REXEED LX: Worldwide Distribution - USA including TN and Germany

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082515ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LXAsahi Kasei Medical Co., Ltd. · 2008-10-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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