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Terminated

Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is indicated for use in attaining long term vascular access for hemodialysis and apheresis in adult patients.

FDA Recall Z-2592-2014 · Posted 2014-09-04

Recalling FirmMedical Components, Inc dba MedComp
Recall StatusTerminated
Product CodeMSD
Date Initiated2014-08-04
Date Terminated2014-12-10
Product Quantity110

Reason for Recall

The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM.

Firm Action

Medcomp sent a Recall Notification letter, dated August 4, 2014, to all affected customers. The letter identified the affected product, problem, and action to be taken. Customers were requested to respond and return all affected product. For questions call contact Susan Smith at [email protected].

Root Cause

Labeling False and Misleading

Distribution Pattern

USA Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121848SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CMMedical Components, Inc. · 2012-09-21

Official Source

View FDA Recall →

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

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