FDAFDA · Food and drugs·Recall number Z-2300-2021
NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
Published August 25, 2021 · Recall initiated: June 21, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Delta Med SpA
- Distributor
- US Nationwide distribution in the states of FL and MN.
- Lot
- REF 3708122, Lot 00A1160627
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Italy
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