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Terminated

Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 19 cm Arterial Cuff/22cm Venous Cuff Code #: 8888-219226

FDA Recall Z-0742-03 · Posted 2003-04-18

Recalling FirmTyco Healthcare/Kendall
Recall StatusTerminated
Date Initiated2003-03-20
Date Terminated2021-05-12
Product Quantity117

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002902TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERSThe Kendall Company · 2001-04-09

Official Source

View FDA Recall →

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

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