Vygon PICC Tray Recall: Sterility Risk from Friction Holes
Vygon recalls PICC Tray (AMS-9093CP) with lot numbers 16I026D and 16J032D due to potential friction holes that could compromise sterility. Affected users should contact Vygon for details.
Lower-risk recall
Potential friction holes may affect the sterility of the product.
Contact the company
What happened, in plain English
Vygon is recalling a PICC tray kit (product code AMS-909:93CP) because friction holes might affect its sterility. This could lead to infections if the tray isn't properly sterilized. The recall covers specific lot numbers. Read more at govinfonow.com/recall/71848-vygon-picc-tray-recall-sterility-risk-from-friction-holes.
Source Summary by GovInfoNow · govinfonow.com/recall/71848-vygon-picc-tray-recall-sterility-risk-from-friction-holes · Updated August 21, 2026 · FDA enforcement record: FDA #Z-1637-2018
Cite this page
“Vygon PICC Tray Recall: Sterility Risk from Friction Holes.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71848-vygon-picc-tray-recall-sterility-risk-from-friction-holes. Based on FDA recall #Z-1637-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1637-2018%22&limit=1).
Why it’s dangerous
Friction holes in the tray could create small openings that allow contaminants to enter the sterile field during use. This might compromise the sterility of the PICC insertion process, increasing infection risk.
Who’s affected
Patients using PICC (peripherally inserted central catheter) lines with this specific tray kit are most at risk. Healthcare providers who use the product for medical procedures may also be affected.
How to tell if you have this one
Check for the product code AMS-9093CP on the tray. The recall includes lot numbers 16I026D and 16J032D. This kit is sold for inserting PICCs into the vascular system.
- Brand
Vygon- Category
Medical device
All 8 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1633-2018 | PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system.; Lot Number: 17B012D UDI: 08498840009802 | 16520 total products |
| Z-1634-2018 | Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system.; Lot Number: 17C060D UDI: 08498840010563 | 16520 total products |
| Z-1635-2018 | Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system.; Lot Number: 17I024D UDI: 08498840010068 | 16520 total products |
| Z-1636-2018 | Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.; Lot Numbers: 17F001D & 17K038D UDI: 08498840004814 | 16520 total products |
| Z-1637-2018 | PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.; Lot Numbers: 16I026D & 16J032D UDI: 08498840004784 | 16520 total products |
| Z-1638-2018 | Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system.; Lot Numbers: 16I025D, 16L026D, 17C014D UDI: 08498840009604 | 16,520 total products |
| Z-1639-2018 | PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.; Lot Numbers: 16I024D, 16H009D, 16I019D, 16J018D, 16L002D, 16L058D, 17B001D, 17B031D, 17C009D, 17C050D, 17F031D, 17F033D, 17H048D, 17F034D, 17H041D, UDI: 08498840009765 | 16,520 total products |
| Z-1640-2018 | PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.; Lot Numbers: 17I040D, 17I041D, 17J016D, 17I002D, 17J015D, 17J018D, UDI: 08498840010648 | 16,520 total products |
What to do — step by step
Check Product Lot Number
Look for lot numbers 16I026D or 16J032D on the tray packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 13 states.
FDA distribution: “Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Connecticut, Florida, Massachusetts, Minnesota, Missouri, New Jersey, Pennsylvania, Texas, Utah, Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1637-2018 (February 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1637-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.