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Manufacturers
Vygon U.S.A.
Manufacturer Address
Vygon U.S.A., 2750 Morris Rd Ste A200, Lansdale PA 19446-6083
Manufacturer Parent Company (2017)
Soc Part Financiere Pierre Simonet
Source
USFDA
8 Events
Recall of Device Recall PICC Insertion Tray
Recall of Device Recall PICC Insertion Tray
Recall of Device Recall Maximum Barrier Tray
Recall of Device Recall PICC Tray
Recall of Device Recall Maximum Barrier Insertion Tray
Recall of Device Recall Maximum Barrier Tray
Recall of Device Recall Neonatal PICC Tray
Recall of Device Recall PICC Kit
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8 devices in the database
Device Recall PICC Insertion Tray
Model / Serial
Lot Numbers: 17I040D, 17I041D, 17J016D, 17I002D, 17J015D, 17J018D, UDI: 08498840010648
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
Product Description
PICC Insertion Tray, Product Code: AMS-7192CS-4 || Convenience kit for the insertion of PICCs into the vascular system.
Device Recall PICC Insertion Tray
Model / Serial
Lot Numbers: 16I024D, 16H009D, 16I019D, 16J018D, 16L002D, 16L058D, 17B001D, 17B031D, 17C009D, 17C050D, 17F031D, 17F033D, 17H048D, 17F034D, 17H041D, UDI: 08498840009765
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
Product Description
PICC Insertion Tray, Product Code: AMS-7192CS-3 || Convenience kit for the insertion of PICCs into the vascular system.
Device Recall Maximum Barrier Tray
Model / Serial
Lot Numbers: 16I025D, 16L026D, 17C014D UDI: 08498840009604
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
Product Description
Maximum Barrier Tray, Product Code: MCITX-1 || Convenience kit for the insertion of PICCs into the vascular system.
Device Recall PICC Tray
Model / Serial
Lot Numbers: 16I026D & 16J032D UDI: 08498840004784
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
Product Description
PICC Tray, Product Code: AMS-9093CP || Convenience kit for the insertion of PICCs into the vascular system.
Device Recall Maximum Barrier Insertion Tray
Model / Serial
Lot Numbers: 17F001D & 17K038D UDI: 08498840004814
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
Product Description
Maximum Barrier Insertion Tray, Product Code: AMS-9152CP || Convenience kit for the insertion of PICCs into the vascular system.
3 more
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