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Terminated

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

FDA Recall Z-0352-04 · Posted 2004-01-14

Recalling FirmToray Marketing & Sales (America), Inc
Recall StatusTerminated
Product CodeFJI
Date Initiated2003-12-30
Date Terminated2004-02-03
Product Quantity384 units

Reason for Recall

Potential loose header (end cap) on hollow fiber dialyzers.

Firm 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.

Root Cause

Other

Distribution Pattern

California, New Jersey, Florida, Texas, Ohio, Wisconsin, New York, and Washington.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002512TORAYSULFONE DIALYZERToray Industries (America), Inc. · 2001-10-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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