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

FDA recall notice · announced April 7, 2021 · Ferring Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.

Notes

Distribution: Nationwide in the USA
Lot/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
Quantity: 1569 devices
Status: Terminated
Products in this recall event:
- 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 H (D-0317-2021)
- 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 (D-0318-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.