Vygon Recalls PICC Insertion Trays Due to Potential Sterility Compromise
Vygon U.S.A. is recalling 16,520 PICC Insertion Trays because potential friction holes may affect the product's 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 where a sterility failure poses a risk of harm (infection), but the source text does not report any specific injuries or illnesses, 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 Insertion Tray (Product Code: AMS-7192CS-4). This convenience kit is used for the insertion of Peripherally Inserted Central Catheters (PICCs) into the vascular system. The recall is being conducted because potential friction holes may affect the sterility of the product.
The affected products were distributed nationwide to the states of Arizona, Utah, Wisconsin, New Jersey, Connecticut, Texas, Pennsylvania, Virginia, Minnesota, Massachusetts, Missouri, Florida, and California. The specific lot numbers involved are 17I040D, 17I041D, 17J016D, 17I002D, 17J015D, and 17J018D. The Universal Device Identifier (UDI) for the product is 08498840010648.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected trays. Users should contact Vygon U.S.A. for instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- PICC Insertion Tray, Product Code: AMS-7192CS-4 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 (7)
- Lot Numbers: 17I040D
- 17I041D
- 17J016D
- 17I002D
- 17J015D
- 17J018D
- UDI: 08498840010648
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 Red Caps Recalled for Defects Causing Leaks
FDA (Devices) · 2019-04-17
- HighVygon DUALSTOP White Caps Recalled for Defect 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
- HighCenturion Neonatal PICC Insertion Tray Recalled for Packaging Compromise
FDA (Devices) · 2019-08-14
- ModerateVygon Recalls Heparin Lock Flush Syringes and PICC Insertion Kits
FDA (Devices) · 2012-06-20
- HighPICC Kit Recall: Outer Bag Pinhole Leaks May Compromise Sterility
FDA (Devices) · 2023-01-18
- HighHCT MAX BARRIER PICC Insertion Tray Recalled for Potential Sterility Breach
FDA (Devices) · 2023-01-18
- ModerateVygon Recalls Pediatric CVC Trays Due to Packaging Adhesive Defect
FDA (Devices) · 2018-02-28
- HighMedline Convenience Kits recalled for potential sterilization issue
FDA (Devices) · 2026-05-13