Z-1996-2014 Class II Terminated

Recalled by RGI Medical Manufacturing, Inc. — Gainesville, FL

Recall Details

Product Type
Devices
Report Date
July 16, 2014
Initiation Date
March 28, 2014
Termination Date
September 29, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19,200 units.

Product Description

Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.

Reason for Recall

Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.

Distribution Pattern

US Nationwide Distribution in the states of AL, CA, DE, GA, IL, KY, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, TN, TX, WA, and WI.

Code Information

Lot numbers 102131 and 110531.