Z-0791-05

Terumo Clirans Series E Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of...

Name: Z-0791-05 Terumo Clirans Series E Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of...
Creator: Asahi Medical Co Ltd
Published: 2005-03-31
License: https://open.fda.gov/license/

Asahi Kasei Medical MT Corp. Oita Works / initiated 2005-03-31 / Terminated

FDA source

Asahi Medical Co Ltd began a recall of Terumo Clirans Series E Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (23 microns thick) of vitamin E... on 2005-03-31. The reason FDA records is "Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0791-05
Status: Terminated
Initiated: 2005-03-31
Posted: 2005-05-03
Terminated: 2006-07-10
Recalling firm: Asahi Kasei Medical MT Corp. Oita Works
Product: Terumo Clirans Series E Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (23 microns thick) of vitamin E coated copolymer cellulose housed within a polyurethane casing, filled at the factory with fluid to facilitate priming by the user, and sterilized by autoclaving before shipment; Terumo Corporation, Tokyo 151-0072, Japan; Terumo Medical Corporation, Somerset, NJ 08873 U.S.A.; Made in Japan, 24 units per case; Models CL*E12NLA - 1.2 m2 surface area, CL*E15NLA - 1.5 m2 surface area, CL*E18NLA - 1.8 m2 surface area and CL*E20NLA - 2.0 m2 surface area
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.
FDA root cause: Other
Action: Asahi sent Henry Schein, Inc. a recall letter dated 3/30/05, requesting the recall of the affected lots of Asahi labeled product, and Henry Schein, Inc. recalled the Asahi labeled dialyzers by letter dated 3/31/05, with a copy of the Asahi 3/30/05 letter. The accounts were informed that the dialyzers may have been exposed to temperature variances during distribution, and werw requested to cease distribution/use of the specific lots listed and return them to Henry Schein for credit. The recall was expanded to include the Terumo labeled dialyzers distributed by Asahi by Henry Schein letter dated 4/13/05, accompanied by a Terumo letter dated 4/8/05, sent to the accounts via first class mail on 4/14/05. The instructions were the same as in the 3/31/05 letter. A revised letter dated 4/21/05 was sent on 4/25/05, correcting the Henry Schein product codes involved in the Terumo labeled product. Any questions were directed Asahi Kasei Medical Co. at 847-498-8500.
Quantity in commerce: 11, 240 units
Distribution: Nationwide and Puerto Rico
Product codes and lots: Schein product code 629-9041, Model CL*E12NLA, lot numbers 040408, 0404080511, 040511, 0405110610, 040610, 040909; Schein product code 629-5978, Model CL*E15NLA, lot numbers 040406, 0404060511, 040511; Schein product code 629-1824, Model CL*E18NLA, lot numbers 031020, 0310201215, 031215; Schein product code 629-7278, Model CL*E20NLA, lot numbers 020604, 0206040711, 020711;

Product code KDI

K003425Class IIClirans E-Series Hollow Fiber DialyzersTerumo Medical Corp. / cleared 2001-02-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)