RGI Medical Manufacturing, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1996-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 28, 2014

Date Posted: July 16, 2014

Recall Number: Z-1996-2014

Event ID: 68552

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.

Status: Terminated

Product Quantity: 19,200 units.

Code Information:

Lot numbers 102131 and 110531.

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.

Voluntary or Mandated:

Voluntary: Firm initiated