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FDA (Drug enforcement)Recalled 2021-03-11closedclass ii

Ferring Pharmaceuticals Inc: 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

Is my product affected?

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

  • UPC 201827020015
  • UPC 201826020065
  • UPC 201835320058
  • UPC 201835320009
  • UPC 201834920003
  • UPC 201835220007
  • UPC 201901820009
  • UPC 201901420200
  • UPC 201902120010
  • UPC 201901120019
  • UPC 201901420005
  • UPC 201901020180
  • UPC 201901520015
  • UPC 201900720001
  • UPC 201900920004
  • UPC 201904620003
  • UPC 201902120011
  • UPC 201904420007
  • UPC 201904520015
  • UPC 201904920002
  • UPC 201905020111
  • UPC 201904620004
  • UPC 201905720011
  • UPC 201907320003
  • UPC 201907320030
  • UPC 201907820007
  • UPC 201907420017
  • UPC 201910820009
  • UPC 201915620014
  • UPC 201910920016
  • UPC 201910620017
  • UPC 201910820020
  • UPC 201911320048
  • UPC 201911320095
  • UPC 201913720148
  • UPC 201912920021

Check against the official notice below — it lists the full affected range.

What happened

Ferring Pharmaceuticals Inc recalled 1,569 ZOMA-Jet 10 Demonstration Kits, which are needle-free delivery devices designed for use with ZOMACTON (somatropin) for injection 10 mg vials. The recall was issued due to customer complaints that the injector pens were breaking apart and disintegrating into pieces, creating a defective delivery system. The affected devices were distributed nationwide in the USA and span multiple lot codes ranging from 201827020015 through 201912920021.

The recall record does not specify a remedy or recommended action for consumers who possess affected devices.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces. Distribution: Nationwide in the USA Quantity: 1569 devices Lot/code info: 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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