Vygon Recalls Neonatal PICC Trays Due to Potential Sterility Issues
Vygon U.S.A. is recalling 16,520 Neonatal PICC 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 is classified as FDA Class II. The hazard involves a potential loss of sterility in a medical device used for vascular access, which presents a risk of harm (infection) even though specific injuries are not reported in the source text.
Plain-English summary
Vygon U.S.A. is recalling 16,520 units of the Neonatal PICC Tray, Product Code AMS-8010CP-1. This product is a convenience kit used for the insertion of peripherally inserted central catheters (PICCs) into the vascular system. The recall is being conducted because potential friction holes may affect the sterility of the product.
The affected units are identified by Lot Number 17C060D and UDI 08498840010563. These 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 stop using the affected Neonatal PICC Trays and contact Vygon U.S.A. for further instructions or a return.
The recalled product
- Product
- Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system.
- Manufacturer
- Vygon U.S.A.
- Category
- Medical Device — Catheters
- 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: 17C060D UDI: 08498840010563
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.
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