Drug product
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.
D-0318-2021
Product summary
- Event
- Event 87455
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1569 devices
- Official record key
drug-enforcement:D-0318-2021
Official wording
Reason: Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Code information: 201827020015 201826020065 201835320058 201835320009 201834920003 201835220007 201901820009 201901420200 201902120010 201901120019 201901420005 201901020180 201901520015 201900720001 201900920004 201904620003 201902120011 201904420007 201904520015 201904920002 201905020111 201904620004 201905720011 201907320003 201907320030 201907820007 201907420017 201910820009 201915620014 201910920016 201910620017 201910820020 201911320048 201911320095 201913720148 201912920021
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.