FDA-Drug2021-04-07Class II
ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 Demonstration Kit contains -ZOMA-Jet 5 device - 5 Needle-Free Head A's - 2 Vial Adaptors - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 18031 5.
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
301 devices
Manufactured in
100 Interpace Pkwy, Parsippany, NJ, United States
Products
ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 Demonstration Kit contains -ZOMA-Jet 5 device - 5 Needle-Free Head A's - 2 Vial Adaptors - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 18031 5.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0317-2021Don't want to check this manually?
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