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Terminated

Tandem-Cath Hemodialysis Cuffed Catheter with no side holes 10 Fr 19 cm Arterial Cuff/22cm Venous Cuff Code #: 8888-219220

FDA Recall Z-0745-03 · Posted 2003-04-18

Recall StatusTerminated
Date Initiated2003-03-20
Date Terminated2021-05-12
Product Quantity215

Reason for Recall

Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter

Firm Action

The firm notified accounts by letter on 3/20/03 by overnight mail delivery. Users are requested to examine, remove and return product.

Root Cause

Other

Distribution Pattern

Nationwide International: Canada, Chile, Singapore. Belgium

Official Source

View FDA Recall →

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

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