The Recall Desk
HighFDA (Devices)·Z-1633-2018·Announced 2018-05-16

Vygon Recalls PICC Insertion Kits Due to Sterility Risk

Vygon U.S.A. is recalling 16,520 PICC Kit units (Product Code AMS-7063-1) 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 involves a medical device with a Class II classification where sterility is compromised. While no illnesses are reported, the risk of infection from non-sterile invasive devices constitutes a high-risk scenario for harm.

Plain-English summary

Vygon U.S.A. has initiated a recall of the PICC Kit, Product Code AMS-7063-1. This convenience kit is designed for the insertion of Peripherally Inserted Central Catheters (PICCs) into the vascular system. The company identified that potential friction holes in the product may affect its sterility.

The recall affects a total of 16,520 units. The affected inventory includes lot number 17B012D and UDI 08498840009802. These products were distributed nationwide to customers in the states of Arizona, Utah, Wisconsin, New Jersey, Connecticut, Texas, Pennsylvania, Virginia, Minnesota, Massachusetts, Missouri, Florida, and California.

Consumers who possess this specific PICC Kit should stop using it immediately due to the risk of compromised sterility. For further details or questions regarding this recall, refer to the official FDA recall notice.

The recalled product

Product
PICC Kit, Product Code: AMS-7063-1 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: 17B012D UDI: 08498840009802

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 compromise

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