Z-2592-2014Class II

Split Cath III Trays, 16F x 28CM

Name: Z-2592-2014 Split Cath III Trays, 16F x 28CM
Creator: Medical Components, Inc dba MedComp
Published: 2014-08-04
License: https://open.fda.gov/license/

Medical Components, Inc. / initiated 2014-08-04 / Terminated / root cause: labeling and UDI

FDA source

Medical Components, Inc dba MedComp began a recall of 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... on 2014-08-04. FDA classified it as Class II and gives the reason as "The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2592-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-04
Posted: 2014-09-04
Terminated: 2014-12-10
Recalling firm: Medical Components, Inc.
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.
Product code: MSD Catheter, Hemodialysis, Implanted
Reason for recall: The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
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].
Quantity in commerce: 110
Distribution: USA Nationwide Distribution
Product codes and lots: TRAY #55216-3; Lot numbers: MBTX960, exp. 10/2016; MBVA850, exp. 10/2016; MBVD080, exp. 01/2017; MBVG680, exp. 01/2017; MBVL020, exp. 01/2017.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2592-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2592-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-10	2014-09-04

Product code MSD

K121848Class IISplit 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

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)