Ferring Recalls ZOMA-Jet 10 Demonstration Kits Due to Defective Delivery System
Ferring Pharmaceuticals is recalling 1,569 ZOMA-Jet 10 Demonstration Kits because the injector pen may break apart and disintegrate into pieces.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect (device disintegrating) poses a risk of physical injury, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Ferring Pharmaceuticals Inc. is recalling 1,569 units of the ZOMA-Jet 10 Demonstration Kit. This needle-free delivery device is used with ZOMACTON (somatropin) for injection 10 mg vials. The kit includes the ZOMA-Jet 10 device, seven Needle-Free Head A's, a carrying case, and a user manual.
The recall was initiated due to customer complaints that the injector pen breaks apart and disintegrates into pieces. This defect presents a risk of injury from the broken components.
The affected products were distributed nationwide in the USA. Consumers should stop using the device immediately and contact Ferring Pharmaceuticals for instructions on how to return the product or obtain a replacement.
The recalled product
- 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…
- Manufacturer
- Ferring Pharmaceuticals Inc
- Affected units
- 1,569
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ferring Pharmaceuticals Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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