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.
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 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.
- 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
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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