Recall Z-2592-2014— Medical Components, Inc dba MedComp

Name: FDA recall Z-2592-2014
Creator: U.S. Food and Drug Administration
Published: 2014-08-04

Class II · Terminated

Class II FDA medical device recall by Medical Components, Inc dba MedComp, initiated 2014-08-04, terminated 2014-12-10. It names one FDA 510(k) clearance: K121848. Product: 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.. Reason: The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM..

Recalling firm: Medical Components, Inc dba MedComp
Classification: Class II
Status: Terminated
Initiated: 2014-08-04
Terminated: 2014-12-10
Firm location: Harleysville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K121848 — SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CMMedical Components, Inc.·cleared 2012-09-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.