Ferring Recalls ZOMA-Jet 5 Demonstration Kits Due to Defective Delivery System
Ferring Pharmaceuticals is recalling 301 ZOMA-Jet 5 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 involves a physical defect (device disintegration) that poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Ferring Pharmaceuticals Inc is recalling 301 units of the ZOMA-Jet 5 Demonstration Kit, a needle-free delivery device used with ZOMACTON (somatropin) for injection. The recall was initiated due to customer complaints that the injector pen breaks apart and disintegrates into pieces.
The affected products were distributed nationwide in the USA. The recall covers specific lot codes: 201601320031, 201702320207, 201731220039, 201817120044, 201912720086, and 201912320044.
Consumers should check their ZOMA-Jet 5 Demonstration Kits for these lot codes and stop using the device if it matches the recalled items. The FDA has classified this as a Class II recall.
The recalled product
- 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…
- Manufacturer
- Ferring Pharmaceuticals Inc
- Affected units
- 301
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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