Vygon Recalls PICC Trays Due to Potential Sterility Compromise
Vygon U.S.A. is recalling 16,520 PICC Trays because potential friction holes may affect the sterility of the product.
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 involves a medical device where a sterility defect poses a risk of harm (infection), but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Vygon U.S.A. is recalling 16,520 units of the PICC Tray, Product Code AMS-9093CP. This product is a convenience kit used for the insertion of PICCs (peripherally inserted central catheters) into the vascular system.
The recall was initiated because potential friction holes may affect the sterility of the product. The affected units are identified by Lot Numbers 16I026D and 16J032D, and UDI 08498840004784.
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 stop using these specific lots and contact the manufacturer for further instructions.
The recalled product
- Product
- PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.
- Manufacturer
- Vygon U.S.A.
- Category
- Medical Device — Catheter Kits
- 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: 16I026D & 16J032D UDI: 08498840004784
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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