FDA-Drug2021-04-07Class II
ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 10 mg vial, ZOMA-Jet 10 Demonstration Kit contains -ZOMA-Jet 10 device - 7 Needle-Free Head A's - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 19031 4.
Ferring Pharmaceuticals Inc
Hazard
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Sold states
Nationwide in the USA
Affected count
1569 devices
Manufactured in
100 Interpace Pkwy, Parsippany, NJ, United States
Products
ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 10 mg vial, ZOMA-Jet 10 Demonstration Kit contains -ZOMA-Jet 10 device - 7 Needle-Free Head A's - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 19031 4.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0318-2021Don't want to check this manually?
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