FDA Medical Device Recalls (openFDA)
Toray Marketing & Sales (America), Inc: Hollow Fiber Dialyzer Model FILTRYZER B1-1.3H
- Recall number
- Z-0349-04
- Recalling firm
- Toray Marketing & Sales (America), Inc
- Product
- Hollow Fiber Dialyzer Model FILTRYZER B1-1.3H
- Status
- Terminated
- Initiated
- 2003-12-30
- Posted
- 2004-01-14
- Terminated
- 2004-02-03
- Reason
- Potential loose header (end cap) on hollow fiber dialyzers.
- 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
- 24 units
- Distribution
- California, New Jersey, Florida, Texas, Ohio, Wisconsin, New York, and Washington.
- Lot, serial or model codes
- 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.)
- 510(k) numbers
- ["K935471"]
- PMA numbers
- not on file
- Product code
- FJI
- Firm FEI
- 3001632632
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28