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.
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 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.
- 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
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
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