The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1996-2014·Announced 2014-07-16

RGI Medical Recalls 300psi I.V. Catheter Extension Sets

RGI Medical is recalling 19,200 units of Henora 300psi I.V. Catheter Extension Sets due to a defect that may cause the tubing to separate from the luer connection during use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a defect that may lead to separation during use, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

RGI Medical Manufacturing, Inc. is recalling 19,200 units of Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Sets. These products are used as catheter extension sets for high-pressure procedures. The recall involves lot numbers 102131 and 110531.

The recall was initiated because of a problem with low adhesion of the tubing to the luer connection. This defect may lead to the separation of the extension set while it is in use. The affected products were distributed nationwide 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.

Healthcare facilities and consumers should stop using the affected products immediately and contact RGI Medical Manufacturing, Inc. for instructions on how to return the items or obtain a replacement.

The recalled product

Product
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
Manufacturer
RGI Medical Manufacturing, Inc.
Category
Medical Device — IV Catheter Extension Set
Hazard
Affected units
19,200

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot numbers 102131 and 110531.

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically:

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