Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Tandem-Cath Hemodialysis Cuffed Catheter with no side holes 10 Fr 28 cm Arterial Cuff/31cm Venous Cuff Code #: 8888-228310

FDA Recall Z-0747-03 · Posted 2003-04-18

Recalling FirmTyco Healthcare/Kendall
Recall StatusTerminated
Date Initiated2003-03-20
Date Terminated2021-05-12
Product Quantity164

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.

↑