Z-0352-04

Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and BS-1.8

Name: Z-0352-04 Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and BS-1.8
Creator: Toray Marketing & Sales (America), Inc
Published: 2003-12-30
License: https://open.fda.gov/license/

Toray International America Inc. / initiated 2003-12-30 / Terminated

FDA source

Toray Marketing & Sales (America), Inc began a recall of Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and BS-1.8 on 2003-12-30. The reason FDA records is "Potential loose header (end cap) on hollow fiber dialyzers". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0352-04
Status: Terminated
Initiated: 2003-12-30
Posted: 2004-01-14
Terminated: 2004-02-03
Recalling firm: Toray International America Inc.
Product: Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and BS-1.8
Product code: FJI Dialyzer, Capillary, Hollow Fiber
Reason for recall: Potential loose header (end cap) on hollow fiber dialyzers.
FDA root cause: Other
Action: Firm notified all consignees by phone call on 1/2/2004 and 1/5/2004. Firm is also notifying all consignees by letter with a response form, sent by certified mail.
Quantity in commerce: 384 units
Distribution: California, New Jersey, Florida, Texas, Ohio, Wisconsin, New York, and Washington.
Product codes and lots: Lot numbers: 20310140, 20910540, and 20910541. (All lot numbers having the last two digits ending in 40 or 41 and having the year of manufacture for individual unit or sterilization date for cases from 01 on a unit and 2001 on to case to 03 and 2003. Expiry year dates are 04 or 2004 to 06 or 2006. An example date is 01 03 09 on a unit which is read 2001 March 09 and for the case with the same date an example would be 2001 03 09.)

Product code FJI

K002512Class IIToraysulfone DialyzerToray Industries (America), Inc. / cleared 2001-10-15

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)