Recall Z-2300-2021— Delta Med SpA
Class II · Ongoing
Class II FDA medical device recall by Delta Med SpA, initiated 2021-06-21. It names one FDA 510(k) clearance: K121007. Product: NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units. Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device.
- Recalling firm
- Delta Med SpA
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-06-21
- Firm location
- Viadana, N/A, Italy
510(k) clearances named in this recall
1 on FDA's record- K121007 — NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
Reason for recall
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Data sourced from openFDA. This site is unofficial and independent of the FDA.