FDAApril 15, 2021device
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection
What to do
FDA enforcement status: Ongoing
Brands named
vygon uvygon
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDA4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S10012019-09-24
- FDAVygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.2018-12-06
- FDAVyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap used for intravascular lines.2018-12-06
- FDAPICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.2018-02-28
- FDAMaximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.2018-02-28
- FDAMaximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system.2018-02-28
- FDAPICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.2018-02-28
- FDAPICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.2018-02-28
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