Z-0528-03
Venus Eye Sphere 12 mm (Sterile)
Gulden Ophthalmics / initiated 2002-11-29 / Terminated / root cause: sterility
Gulden Ophthalmics began a recall of Venus Eye Sphere 12 mm (Sterile) on . The reason FDA records is "lack of sterility assurance". As of , the recall status on record is Terminated, and MDM tags the root cause as sterility.
Recall record
- Recall number
- Z-0528-03
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Gulden Ophthalmics
- Product
- Venus Eye Sphere 12 mm (Sterile)
- Product code
- HQX Implant, Orbital, Extra-Ocular
- Reason for recall
- lack of sterility assurance
- Root cause tag
- sterility
- FDA root cause
- Other
- Action
- The recalling firm issued letters to the accounts requesting the return of the devices.
- Distribution
- Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand
- Product codes and lots
- model number 14151. lot number 8284
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