Vygon Recalls PICC Insertion Trays Due to Potential Sterility Issues
Vygon U.S.A. is recalling 16,520 PICC Insertion 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 is classified as FDA Class II. The hazard involves a potential loss of sterility in a medical device used for vascular insertion, which presents a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Vygon U.S.A. is recalling 16,520 units of the PICC Insertion Tray, Product Code AMS-7192CS-3. This product is a convenience kit used for the insertion of Peripherally Inserted Central Catheters (PICCs) into the vascular system.
The recall was initiated because potential friction holes may affect the sterility of the product. The affected units were distributed nationwide to the states of Arizona, Utah, Wisconsin, New Jersey, Connecticut, Texas, Pennsylvania, Virginia, Minnesota, Massachusetts, Missouri, Florida, and California.
The affected lot numbers are 16I024D, 16H009D, 16I019D, 16J018D, 16L002D, 16L058D, 17B001D, 17B031D, 17C009D, 17C050D, 17F031D, 17F033D, 17H048D, 17F034D, and 17H041D. The Universal Device Identifier (UDI) is 08498840009765. Healthcare facilities and consumers should stop using these products and contact the manufacturer for further instructions.
The recalled product
- Product
- PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.
- Manufacturer
- Vygon U.S.A.
- Category
- Medical Device — Surgical 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 (16)
- Lot Numbers: 16I024D
- 16H009D
- 16I019D
- 16J018D
- 16L002D
- 16L058D
- 17B001D
- 17B031D
- 17C009D
- 17C050D
- 17F031D
- 17F033D
- 17H048D
- 17F034D
- 17H041D
- UDI: 08498840009765
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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