Drug product
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.
D-0317-2021
Product summary
- Event
- Event 87455
- Status
- Terminated
- Classification
- Class II
- Quantity
- 301 devices
- Official record key
drug-enforcement:D-0317-2021
Official wording
Reason: Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Code information: 201601320031 201702320207 201731220039 201817120044 201912720086 201912320044
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.