Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter

FDA device recall Z-2418-2012 · posted 2012-09-20 · Terminated

Recall details

Recalling firm

Asahi Kasei Medical Co., Ltd., Okatomi Plant

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.

Action taken

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

Status

Terminated

Product code

KDI

Quantity affected

55,632 units

Distribution

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

Date initiated

2012-09-21

Date posted

2012-09-20

Date terminated

2013-02-05

Location

Nobeoka-shi, 5 Chome, Japan

Related 510(k) clearances