The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1638-2018·Announced 2018-05-16

Vygon Recalls Maximum Barrier Tray Due to Potential Sterility Compromise

Vygon U.S.A. is recalling the Maximum Barrier Tray (Product Code MCITX-1) because potential friction holes may affect the product's 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 is FDA Class II and involves a medical device where sterility may be compromised, posing a risk of harm to patients. However, the source text does not report any actual illnesses or injuries, placing it at the High severity level rather than Severe.

Plain-English summary

Vygon U.S.A. is voluntarily recalling the Maximum Barrier Tray, Product Code MCITX-1. This convenience kit is designed for the insertion of peripherally inserted central catheters (PICCs) into the vascular system. A total of 16,520 units are subject to this recall.

The recall was initiated because potential friction holes may affect the sterility of the product. The affected products were distributed nationwide to the states of Arizona, Utah, Wisconsin, New Jersey, Connecticut, Texas, Pennsylvania, Virginia, Minnesota, Massachusetts, Missouri, Florida, and California.

Products involved in this recall have lot numbers 16I025D, 16L026D, and 17C014D, with UDI 08498840009604. Consumers who possess these products should stop using them immediately.

The recalled product

Product
Maximum Barrier Tray, Product Code: MCITX-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 (3)

  • Lot Numbers: 16I025D
  • 16L026D
  • 17C014D UDI: 08498840009604

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 →

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