Hollow Fiber Dialyzer Model FILTRYZER B3-1.0A, B3 -1.3A, and B3-1.6a
- Recall Initiated
- December 30, 2003
- Posted
- January 14, 2004
- Terminated
- February 3, 2004
- Recall Number
- Z-0350-04
- Quantity
- 108 units
- Firm Location
- Houston, TX
Reason for Recall
Potential loose header (end cap) on hollow fiber dialyzers.
Distribution
California, New Jersey, Florida, Texas, Ohio, Wisconsin, New York, and Washington.
Lot / Code Info
Lot numbers: 10630840, 10230940, and 20230540. (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.)
Root Cause
Other
Action Taken
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.
More recalls by Toray Marketing & Sales (America), Inc
Hollow Fiber Dialyzer Model FILTRYZER B1-1.3H
Jan 14, 2004
Hollow Fiber Dialyzer, Model FILTRYZER BK-2.IU
Jan 14, 2004