Toray Marketing & Sales (America), Inc Hollow Fiber Dialyzer Model FILTRYZER B1-1.3H Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Hollow Fiber Dialyzer Model FILTRYZER B1-1.3H
Brand
Toray Marketing & Sales (America), Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot 10830640 (All lot numbers having the last two digits ending in 40 or 41 and having the year of manufacture for individual units 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.)
Toray Marketing & Sales (America), Inc is recalling Hollow Fiber Dialyzer Model FILTRYZER B1-1.3H due to Potential loose header (end cap) on hollow fiber dialyzers.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential loose header (end cap) on hollow fiber dialyzers.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, NJ, NY, OH, TX, WA, WI
Page updated: Jan 10, 2026