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.
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 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.
See all 8 products in this recall →Related recalls
Same manufacturer · Vygon U.S.A.
See all →- HighVygon Dressing Change Kit Recalled for Sterile Barrier Failure Risk
FDA (Devices) · 2021-06-09
- HighVygon DUALSTOP White Caps Recalled for Defect Causing Leaks
FDA (Devices) · 2019-04-17
- HighVygon DUALSTOP Red Caps Recalled for Defects Causing Leaks
FDA (Devices) · 2019-04-17
- HighVygon U.S.A. Recalls Maximum Barrier Tray Due to Sterility Risk
FDA (Devices) · 2018-05-16
- HighVygon Maximum Barrier Insertion Tray Recalled for Potential Sterility Compromise
FDA (Devices) · 2018-05-16
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateVygon Recalls Pediatric CVC Trays Due to Packaging Adhesive Defect
FDA (Devices) · 2018-02-28
- HighCenturion Neonatal PICC Insertion Tray Recalled for Packaging Compromise
FDA (Devices) · 2019-08-14
- HighStradis Healthcare Neonatal PICC Trays recalled for potential sterility breach
FDA (Devices) · 2023-01-18
- HighPICC Kit Recall: Outer Bag Pinhole Leaks May Compromise Sterility
FDA (Devices) · 2023-01-18
- HighMedline Convenience Kits recalled for potential sterilization issue
FDA (Devices) · 2026-05-13
- HighNeonatal PICC Tray Recalled Due to Potential Sterility Breach
FDA (Devices) · 2023-01-18