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Recall Observatory FDA recall evidence

Device product

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

Z-1996-2014

March 28, 2014

Class II

Product summary

Firm
RGI Medical Manufacturing, Inc.
Event
Event 68552
Status
Terminated
Classification
Class II
Quantity
19,200 units.
Official record key
device-enforcement:Z-1996-2014

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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