PlainRecalls
FDA Devices Moderate Class II 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.

Reported: September 10, 2014 Initiated: August 4, 2014 #Z-2592-2014

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.

Details

Units Affected
110
Distribution
USA Nationwide Distribution
Location
Harleysville, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Medical Components, Inc dba MedComp. Units affected: 110.
Why was this product recalled?
The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 10, 2014. Severity: Moderate. Recall number: Z-2592-2014.