Vygon U.S.A.: PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.

Is my product affected?

PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.

• UPC 08498840009765

Check against the official notice below — it lists the full affected range.

What happened

Vygon U.S.A. is recalling 16,520 PICC Insertion Trays (Product Code: AMS-7192CS-3) used for inserting peripherally inserted central catheters into the vascular system. The recall affects specific lot numbers distributed nationwide to Arizona, Utah, Wisconsin, New Jersey, Connecticut, Texas, Pennsylvania, Virginia, Minnesota, Massachusetts, Missouri, Florida, and California. The products are being recalled because potential friction holes may compromise the sterility of the trays.

The recall notice does not specify a remedy or what actions affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Potential friction holes may affect the sterility of the product.

Details from the source

Reason for recall: Potential friction holes may affect the sterility of the product. Distribution: Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA. Quantity: 16,520 total products Lot/code info: Lot Numbers: 16I024D, 16H009D, 16I019D, 16J018D, 16L002D, 16L058D, 17B001D, 17B031D, 17C009D, 17C050D, 17F031D, 17F033D, 17H048D, 17F034D, 17H041D, UDI: 08498840009765

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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