The Recall Desk
HighFDA (Devices)·Z-1635-2018·Announced 2018-05-16

Vygon U.S.A. Recalls Maximum Barrier Tray Due to Sterility Risk

Vygon U.S.A. is recalling the Maximum Barrier Tray (Product Code AMS-9018CP) because potential friction holes may compromise product 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 FDA Class II involving a medical device where sterility may be compromised, posing a risk of harm to patients without yet reported illness or injury.

Plain-English summary

Vygon U.S.A. has initiated a recall of the Maximum Barrier Tray, Product Code AMS-9018CP. This product is described as a convenience kit designed for the insertion of PICCs (Peripherally Inserted Central Catheters) into the vascular system. The company identified that potential friction holes may affect the sterility of the product.

The recall affects 16,520 total units distributed nationwide to customers in Arizona, Utah, Wisconsin, New Jersey, Connecticut, Texas, Pennsylvania, Virginia, Minnesota, Massachusetts, Missouri, Florida, and California. The specific lot number subject to this recall is 17I024D, with UDI 08498840010068.

Consumers who possess this product should stop using it immediately and contact Vygon U.S.A. for further instructions regarding return or replacement.

The recalled product

Product
Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system.
Manufacturer
Vygon U.S.A.
Category
Medical Device — PICC Insertion Kit
Hazard
Affected units
16,520

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: 17I024D UDI: 08498840010068

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Part of a larger recall action

This product is one of 8 recalled by Vygon U.S.A. 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 8 products in this recall →

Related recalls

Same manufacturer · Vygon U.S.A.

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Same hazard · sterility loss

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