Vygon Maximum Barrier Insertion Tray Recalled for Potential Sterility Compromise
Vygon U.S.A. is recalling Maximum Barrier Insertion Trays 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 involves a sterile medical device where a defect (friction holes) may compromise sterility, posing a risk of harm without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Vygon U.S.A. is recalling the Maximum Barrier Insertion Tray, Product Code AMS-9152CP. This product is a convenience kit used for the insertion of PICCs into the vascular system. The recall involves 16,520 total products.
The recall was initiated because potential friction holes may affect the sterility of the product. The affected lot numbers are 17F001D and 17K038D, with UDI 08498840004814.
The products were distributed nationwide to the states of Arizona, Utah, Wisconsin, New Jersey, Connecticut, Texas, Pennsylvania, Virginia, Minnesota, Massachusetts, Missouri, Florida, and California. Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected products.
The recalled product
- Product
- Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.
- Manufacturer
- Vygon U.S.A.
- 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 Numbers: 17F001D & 17K038D UDI: 08498840004814
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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