The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0293-2020·Announced 2019-11-13

Argon Medical Devices Recalls Vascuclamp Vascular Clamps Due to Sterility Risk

Argon Medical Devices is recalling Vascuclamp radiopaque vascular clamps because an incomplete pouch seal may cause a loss of sterility.

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 risk-of-harm product (loss of sterility) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

Argon Medical Devices, Inc. is recalling four models of Vascuclamp radiopaque vascular clamps. The affected products are sterile, prescription-only medical devices distributed nationwide and to Canada, Australia, the Netherlands, and Spain. The total number of units in the recall is 49,130.

The recall is being conducted because the seal formed on the edge of the product pouch may be incomplete. This defect could result in a loss of sterility to the product. The specific lot numbers affected are 11230432, 11226690, 11231581, 11227669, 11228371, and 11230677.

Healthcare facilities and distributors should stop using the affected clamps and contact Argon Medical Devices for instructions on how to return the products.

The recalled product

Product
(1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxes/case, Sterile, Rx; (2) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Straight, REF 046-1-300, 2 clamps per package…
Manufacturer
Argon Medical Devices, Inc
Category
Medical Device — Surgical Instruments
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 (11)

  • (1) Argon Medical Devices Vascuclamp
  • Radiopaque Vascular Clamp
  • Small Straight
  • REF 046-1-200 - Lot number 11230432
  • (2) Argon Medical Devices Vascuclamp
  • Medium Straight
  • Medium Angled
  • REF 046-1-301 - Lot number 11227669
  • (4) Argon Medical Devices Vascuclamp
  • Large Angled
  • REF 046-1-401 - Lot numbers 11228371 and 11230677.

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 →

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