The Recall Desk
HighFDA (Devices)·Z-0291-2020·Announced 2019-11-13

Argon Medical Devices Recalls TRI-JECT IV Organizers Due to Seal Defect

Argon Medical Devices is recalling 49,130 units of TRI-JECT 3 Way IV Administration Organizers because an incomplete seal may cause loss of sterility.

What this means for you

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 is classified as FDA Class II and involves a risk of loss of sterility in a medical device, which fits the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Argon Medical Devices, Inc. is recalling 49,130 units of TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF 041230001A. The recall affects Lot number 11226919. The product is a sterile, prescription-only medical device distributed in boxes of 25.

The recall was initiated because the seal formed on the edge of the pouch may be incomplete. This defect could result in a loss of sterility to the product. The agency has classified this recall as Class II.

Distribution was nationwide, including military and government channels. The product was also distributed to Canada, Australia, the Netherlands, and Spain. Healthcare facilities and consumers should stop using the affected product and contact the manufacturer for instructions.

The recalled product

Product
Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF 041230001A, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Manufacturer
Argon Medical Devices, Inc
Category
Medical Device — IV Administration
Hazard
Affected units
49,130

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 number 11226919

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Argon Medical Devices, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Related recalls

Same manufacturer · Argon Medical Devices, Inc

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Same hazard · loss of sterility

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